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2016 Quality Management System Vendor Software Benchmark Report

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The 2016 Quality Management System Vendor Software Benchmark Report is a survey across industries and geographies on IT/Technology systems used today for Quality Systems across the product or service value chain. The 2016 Survey had over 400+ participants world-wide. Comparisons to 2015 Benchmark are also included. A complete Vendor Listing is located in Appendix II.

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2016 Quality Management System Vendor Software Benchmark Report

  1. 1. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.
  2. 2. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SPECIAL SPONSORSHIP BY 2Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns.
  3. 3. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INTRODUCTION 3Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. The purpose of this survey was to collect data from companies on enabling technology currently used to support key areas of their Quality Management System. Data was collected from the LinkedIn Quality & Regulatory Network group representing over 109,000 professionals worldwide. Over 400 members from multiple industries participated. Percentages do not reflect data for market size, vendor market share or leadership position. Data only reflects vendor selections from survey participants. Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix. Not all vendors may be represented in their category. If you are a Vendor that is not currently on our list, we welcome the chance to have you participate in the 2017 QMS Vendors Benchmark Survey. Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality & Regulatory Network. The Quality & Regulatory Network would like to thank our helpers in creating the base report. I would also like to give special recognition and thanks to my Partners C.M. Schramm and Bob Mehta for their on-going support and help in getting this report finished. I couldn’t do this without their expertise, dedication and quality control. Thank you Clare and Bob! LinkedIn, the LinkedIn logo, the IN logo and InMail are registered trademarks or trademarks of LinkedIn Corporation and its affiliates in the United States and/or other countries. All other references to company and product names are copyright in their own right.
  4. 4. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SPECIAL THANK YOU TO OUR 2016 SPONSORS 4Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. A very big thank you to our Platinum Sponsor, Arena Solutions, and all of our sponsors – Gold, Silver and Bronze. Your kind support allows us the resources to research, analyze and finalize the QMS Benchmark Report. An additional thank you goes out to our media sponsors helping us to announce the Survey Launch and Final Report availability. Thanks again!Cognizant MedVantage Cybermetrics FormPipe MasterControl Motto Systems Traction Software PLATINUM SPONSOR BRONZE SPONSORS SILVER SPONSORS GOLD SPONSORS MEDIA SPONSORS
  5. 5. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by OBSERVATIONS AND COMMENTS FOR 2016 Demographics - Industry Not surprising that the Life Sciences (Biotech, Medical Device, Pharmaceuticals) industry maintains the leadership position in responding to the Survey as thy are the most vocal in the LinkedIn Quality & Regulatory Network group. However, we are seeing growth in other industries such as Laboratories potentially impacted by Health Care regulations or threat to move control under FDA. With the growing complexity of global regulatory changes and their impact on Quality, larger companies are trying to improve their visibility across the entire enterprise by consolidating and standardizing on a single QMS platform. More large and boutique consulting firms are now recognizing that Quality and its QMS software are taking a more prominent role in the supply chain with enterprise system implementations. Not quite an ERP implementation complexity, but the paradigm shift from easily managed site “antiquated” systems and paper-based models are causing challenges in enterprise-wide cultural adoption that change and automation are a “good thing.” Greater facilitation and leadership support will be greatly needed to see the change in the Quality Maturity to the next level. Demographics - Company Size / Revenue Half of the participants were from small companies with revenues less than 100M. The interest in deciding on keeping paper or starting with automation as they progress to their first product submissions is high on the minds of these companies. Although low in funding for automation, many of these companies are seeing the benefits of starting automation now, such as Document Management, to set the structure of the company before it becomes wild and crazy with barely a breath to stop and consider trying to fit in an electronic system implementation. These small companies are ideal to leverage the technology, sustainability and cost of Cloud-based solutions. Demographics – Survey Participants More than 80% of the (blind) participants took this survey for the first time. Some participants may have not taken the survey again has things had not changed from previous years. To be more accurate in our figures, we are looking at ways for prior participants to easily state that the new year hasn’t really changed. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 5
  6. 6. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by OBSERVATIONS AND COMMENTS FOR 2016 Functional Categories – Vendor Profiles A plethora of vendors were selected for each of the categories, as seen in the charts. These may be a result of companies having more than one system and therefore doing a multi-selection or the result of the new Cloud-born solutions representing the smaller companies embracing the technology into their overall growth plan. A few of these vendors listed last year are no longer with us showing us only the strong survive or get acquired. Some Feedback from Participants Concerning their System of Use: • Licensing costs for companies consolidating into one instance for the enterprise • Companies need to stay on top of the vendor during implementation • Length of time some systems take to get up and running • Global use is hindered by time zone issues • Consolidation, migration and cultural adoption • Workflow process is complex to configure and maintain • Challenge or lack of interfaces to other manufacturing and document management systems • Standard QMS does not work well with contract manufacturers • Need better interface between call center system and complaint handling solution. Vendor does not have good business sense of different call types. • Need guide for country jurisdiction and regulations of complaints globally • Many solutions not providing OOS especially for lab • Not all QMS systems connect well with GMP Training System • Support outside the client time zone • Validation challenges • Cost is high • User interface is not intuitive • Not impressed with Top IT provider GxP capabilities and understanding business needs Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 6
  7. 7. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by OBSERVATIONS AND COMMENTS FOR 2016 Most of the comments were focused on the difficulty of implementation, especially global, working with the software vendor and finally costs. Larger companies are maturing and through M&As have the need to consolidate all their systems into a single enterprise instance. With that comes the cost not just from the vendor, but the internal costs spent on having dedicated resources from IT and especially business throughout the entire project. Vendors need guidance and may not understand the terminology of the business. Complexities like data migration, multiple integration, master data and archiving are all things that need to be planned upfront before finding out too late additional requirements and complexities that just pop up. Some solutions like Calibration and SPC especially at a plant site, although critical to the overall manufacturing process, is not the highest priority in converting to an automated solution and hence many are still using manual processes (including index cards). The interest from quality and manufacturing engineers is high to help reduce work overload, but the progress is slow. Most are satisfied if they move to the functionality contained within their ERP or just tracking solutions provided by QMS software vendors. Complaint handling and CAPA may be the ones that have more complex process of all the functional areas, but after all a CAPA is a CAPA. However, those organizations that try to replicate their paper-based processes, may just find the things that weren’t working before in a manual process are still not working when automated. This is because companies are trying to automate every detail for every type of workflow around each specific product class, country, and other attributes, or are trying to force-fit functionality into a software solution not built for it. Each approach causes complexity and typically results in a user interface that is not intuitive especially for infrequent users. Customization or lengthy configurations will also make the cost higher for implementation and maintenance. Good rule is 80% out-of-the-box and 20% formatting changes or additional configuration. Lastly, with the changing global regulatory landscape, companies not only need to think of country jurisdiction when a complaint occurs but bring regulatory into the fold of manufacturing release so the right product is released to the right country at the right time. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 7
  8. 8. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by OBSERVATIONS AND COMMENTS FOR 2016 Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 8 LIMS and MES still appear to have automation adoption challenges. A lot of companies are using manual processes in the lab or on the shop floor. Although a lot of opportunity for growth, typically there is no clear strategy for automation or integration with other systems. Batch records are still predominantly paper-based, a risk for accuracy and compliance, and you can still find rooms filled with locked cabinets. Still considered a relatively new idea in some industries, we’ve seen changes recently with PLM. In the past, PLM was owned by Development/Engineering. However, since Quality is across the entire product value chain we are now seeing many organization shift the ownership to Quality resulting in PLM vendors adding more functionality to support product quality lifecycle. Although on the rise, many companies still lack a PLM and try to make up for it by using many different systems – adding to the complexity for their users. It’s not surprising to hear that Top IT providers implementing quality solutions do not have impressive GxP capabilities nor understand the business. SMEs with a background in GMP, Validation, Quality and how it’s applied with Vendor Software are the ones that can provide guidance to an IT provider during a project implementation. This role is critical to any QMS implementation success. But do not think that all delivery people whether on-shore or off-shore will have this kind of knowledge except for what they hear when on-boarded to the project.
  9. 9. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by OBSERVATIONS AND COMMENTS FOR 2016 Technology Trends Last year there were a greater number of participants saying they had no cloud-based solutions within their organization. This year is 50% less. Although Cloud technologies increasingly become mainstream, only 30% of respondents think Cloud is a positive trend for Quality Management Systems. While many organizations embrace Cloud, security and regulatory compliance concerns are a limiting factor to broader adoption. Lack of GAMP and FDA guidelines for SaaS and Cloud-based systems are also a major concern. Although Cloud and security was mentioned many times, the biggest trends that participants are watching are Mobility and Digital Transformation Other Observations – Years Used, Satisfaction, Installation, Implementation Most participants said they have been using their systems from 1-3 years and only a small portion had something implemented within the last year. As companies may evaluate their software lifecycle from 3-5 years, we might see an uptick in new system acquisitions especially for CAPA, nonconformances and deviations especially on the shop floor and replacing old or adding new document management systems. The uptick in Document Management can be either small companies embracing automation or a plethora of lower cost Cloud solutions being available. For the most part, even seeing issues and challenges with their system and vendor as part of the survey feedback, participants mostly felt good about their QMS system. Companies are still trying to everything themselves including implementing QMS systems with some help from the vendor. This approach may be overwhelming to IT and especially to Business and may cause a company to miss out on the benefits of leading practices that both a software vendor and service providers can provide from vast experience with customers. Over run projects, difficulties keeping to schedules is not the fault of internal resources nor vendors, but the lack of having resources dedicating time to a project. Consideration on external resources may be need to help drive the strategy and roadmap before jumping directly into a large program implementation, especially those that are enterprise-wide or have multiple business units involved. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 9
  10. 10. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by NUMBER ONE CHALLENGE Although cost is always on the top 3 of the list of challenges in implementing a Quality system, the feedback on the number one challenge is cultural adoption. Users comfortable with paper need early training on the benefits of automation for their own job, department and company. In addition, the voice of the company needs to be heard even if implementation will be done in another phase or year. Leaders need to be very supportive and help commit to the long term investment. If culture is not considered as part of planning phase of a new Quality system, there will be greater potentials for failures. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 10  IF YOU’RE GOING TO RISE TO THE CHALLENGE, YOU HAVE TO BE PREPARED TO CHANGE.
  11. 11. Internal/External Audit Calibration & Maintenance CAPA (Corrective & Preventive Actions) Change Control Complaints Document Management Exceptions (Deviations, Non-conformances) Environmental Health & Safety (EH&S) Laboratory Management (LIMS, ELN) Manufacturing Execution System (MES) Product Lifecycle Management (PLM) Statistical Process Control (SPC/PAT) Supplier Quality Training SaaS / Cloud Systems Usage Challenge in Implementation Technology Trends Impacting QMS Resources Needed for On-Going QMS success Selected Comments from Participants Appendix I –Selected Vendor Profiles Appendix II –Vendor List Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.
  12. 12. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 12Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY 1.1% 1.3% 1.1% 1.3% 10.5% 1.3% 1.6% 11.1% 2.9% 2.6% 2.1% 1.3% 1.6% 12.4% 10.3% 1.8% 21.1% 3.4% 11.2% Academic Research Aerospace & Defense Airlines / Aviation Automotive Biotechnology Chemicals Contract Partner Consulting Electrical & Electronic Manufacturing Food & Beverages Hospital & Health Care Information Technology & Services Laboratory Life Science Multi-Sector Medical Device / Diagnostic / Software Mining, Metals, Paper, Plastics Pharmaceuticals Software Vendor for QMS Other Bio Med Pharma Life Science Multi-Sector
  13. 13. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF INDUSTRY TO 2015 13Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 1.1% 1.3% 1.1% 1.3% 10.5% 1.3% 1.6% 11.1% 2.9% 2.6% 2.1% 1.3% 1.6% 12.4% 10.3% 1.8% 21.1% 3.4% 11.2% 3.5% 1.5% 12.4% 1.1% 1.3% 4.3% 3.8% 4.6% 17.6% 35.5% 14.4% 0% 5% 10% 15% 20% 25% 30% 35% 40% 2016 2015
  14. 14. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 14Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE M – Million B - Billion 31.8% 15.8% 8.4% 12.4% 3.7% 3.9% 10.5% 6.6% 2.9% 1.6% 2.4% less than 25M 26-50M 51-100M 101-500M 500-750M 750M-1B 1-5B 5-10B 11-25B 26-50B Over 50B
  15. 15. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF ANNUAL REVENUE TO 2015 15Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 38.4% 34.8% 8.9% 17.9% 31.8% 15.8% 8.4% 12.4% 3.7% 3.9% 10.5% 6.6% 2.9% 1.6% 2.4% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 2015 2016
  16. 16. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR ROLE OR FUNCTION WITHIN THE COMPANY 16Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 5.5% 5.5% 2.1% 8.7% 4.5% 4.2% 39.2% 3.4% 3.4% 0.5% 0.8% 1.6% 0.3% 0.5% 0.3% 2.9% 16.6% Compliance Engineering Exec/C-Suite IT Management Manufacturing Quality Assurance Quality Control Regulatory Risk R&D Safety Security Supply Chain Sustainability Training / HR Validation
  17. 17. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF ROLES TO 2015 17Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Note: Some answers were consolidated under one industry while those with only a single response were allocated to "Other." 8.2% 5.7% 8.7% 3.1% 35.3% 15.4% 7.5% 0.1% 2.7% 0.6% 0.7% 0.3% 11.7%5.5% 5.5% 2.1% 8.7% 4.5% 4.2% 39.2% 3.4% 3.4% 0.5% 0.8% 1.6% 0.3% 0.5% 0.3% 2.9% 16.6% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 2015 2016
  18. 18. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by DEMOGRAPHICS 2016 REPRESENTATION FROM PARTICIPANTS ABOUT THEIR GEOGRAPHICAL REGION 18Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 64.7% 1.6% 0.8% 12.6% 0.3% 2.1% 0.8% 17.1% North America Central America South America Europe Eastern Europe Africa Middle East Asia Pacific
  19. 19. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF GEOGRAPHICAL REPRESENTATION TO 2015 19Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 62% 14% 20% 2% 2% 13% 64.7% 1.6% 0.8% 12.6% 0.3% 2.1% 0.8% 17.1% 0% 10% 20% 30% 40% 50% 60% 70% North America Central America South America Europe Eastern Europe Africa Middle East Asia Pacific 2015 2016
  20. 20. 20Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Please note that each Category has 5 parts: • Top 2016 Vendors Selected • Vendor list of “Other” with less than 1% response • Time & Satisfaction with the System • Installation & Implementation of the System • Comparison to the 2015 Benchmark
  21. 21. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INTERNAL / EXTERNAL AUDIT SYSTEM 21 Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 24% 1% 27% 1%1% 10% 4% 1% 7% 1% 3% 3% 5% 2% 2% 5% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) AutoSHEQ Cebos ETQ GMPPro (MOTTO Systems) JIRA (Atlassian) MasterControl Q-Pulse (Gael) SAP SharePoint (Microsoft) Trackwise (Sparta Systems) Verse ZenQMS Other
  22. 22. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER AUDIT VENDORS* 123Compliance (Sparta Systems) AMPLEXOR Compliance Control ComplianceQuest Documentum Compliance Manager Ennov Software Solutions Enovia PLM (Dassault Systemes) Formpipe.GxP (Formpipe Software AB) Harrington Group International HP Quality Center (QC) IQS, Inc. MetricStream NextDocs Optiva PLM (Infor) Oracle QA Systems (QASYS) QAD QPR Software PLC Qualtrax Qumas (Dassault Systemes) Rescop Salesforce ServiceNow 22Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  23. 23. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 4% 8% 24% 37% 28% Awful Poor Average Good Excellent 20.9% 27.2% 13.7% 5.1% 14.3% < 1 year 1-3 years 4-6 years 7-9 years > 10 years TIME SATISFACTION TIME & SATISFACTION WITH AUDIT SYSTEM 23Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.
  24. 24. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF AUDIT SYSTEM 24Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 33.7% 31.6% 2.1% 0.9% 0.9% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider 32.8%6.6% 8.7% 5.4% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant INSTALLATION IMPLEMENTATION
  25. 25. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF AUDIT TO 2015 25Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 23.6% 1.2% 27.4% 1.7% 1.7% 10.1% 3.7% 0.0% 1.7% 7.5% 0.9% 0.3% 1.4% 3.2% 2.6% 5.5% 2.0% 2.0% 24.6% 7.1% 17.9% 0.0% 0.5% 1.5% 0.7% 2.1% 1.2% 6.0% 2.3% 1.8% 1.8% 4.6% 3.5% 6.9% 0.3% 1.0% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 2016 2015
  26. 26. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by CALIBRATION & MAINTENANCE (CMMS & PM) 26 Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in the list of other Vendors. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 21.7% 4.5% 21.3% 1.4% 3.6%4.5% 1.4% 5.4% 1.8% 5.9% 1.4% 1.8% 1.4% 4.5% 1.8% 1.4% 5.9% 10.4% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) AutoSHEQ Blue Mountain Calman (SpectraCal) Cebos ETQ GAGEtrak (CyberMetrics Corporation) GMPPro (MOTTO Systems) IQS, Inc. JD Edwards (Oracle) MasterControl Maximo (IBM) ProCAL (Prime Technologies) Q-Pulse (Gael) SAP Other
  27. 27. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER CALIBRATION & MAINTENANCE VENDORS* Access Automation (UCAL) Ape Software CERDAAC (Simco Electronics) Gage Insite (Indysoft Corporation) GageManager (Altegra) GAGEpack (PQ Systems) iBASEt IBS US Infor EAMS LabVantage Labware QAD Quality Systems Toolbox Rescop TrackPro uniPoint Software Vintara 27Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  28. 28. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH CALIBRATION & MAINTENANCE SYSTEM 28Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. TIME SATISFACTION 11.5% 23.4% 8.7% 4.8% 31.7% 1-3 years 4-6 years 7-9 years Other 3% 13% 29% 32% 23% Awful Poor Average Good Excellent
  29. 29. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF CALIBRATION & MAINTENANCE SYSTEM 29Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. INSTALLATION IMPLEMENTATION 31.7% 3.2% 4.8% 2.2% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 37.3% 37.3% 3.1% 0.3% 0.7% 21.4% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider Other
  30. 30. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF CALIBRATION & MAINTENANCE TO 2015 30Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 17.0% 3.5% 16.6% 4.6% 4.6% 4.2% 3.5% 3.5% 2.8% 1.4% 1.4% 1.4% 14.4% 3.2% 0.9% 1.4% 4.5% 0.9% 0.2% 4.2% 8.0% 0.0% 1.7% 0.9% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 2016 2015
  31. 31. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 31 SponsoredBy What else do you want to see in the 2017 QMS Vendor Report? Submit Now!
  32. 32. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by CAPA (CORRECTIVE & PREVENTIVE ACTIONS) 32Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 16.0% 2.3% 21.7% 1.0% 13.7% 4.3% 1.3% 8.7% 1.0% 1.7% 1.0% 2.0% 2.3% 8.0% 2.3% 3.3% 9.3% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) AutoSHEQ ETQ GMPPro (MOTTO Systems) IQS, Inc. MasterControl Pilgrim Q-Pulse (Gael) Qumas (Dassault Systemes) SAP SharePoint (Microsoft) Trackwise (Sparta Systems) Verse ZenQMS Other
  33. 33. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER CAPA VENDORS* 123Compliance Cebos ComplianceQuest Empower PLM (Omnify Software) Ideagen PLC JIRA (Atlassian) MetricStream Omnex QPR Software PLC Qualtrax Redmine Rescop TeamPage (Traction Software) uniPoint Software 33Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  34. 34. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH CAPA SYSTEM 34Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 18.0% 35.3% 12.9% 6.1% 11.2% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 4% 8% 23% 35% 31% Awful Poor Average Good Excellent
  35. 35. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF CAPA 35Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. INSTALLATION IMPLEMENTATION 37.3% 37.3% 3.1% 0.3% 0.7% 21.4% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider 37.3% 6.4% 8.5% 6.4% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant
  36. 36. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF CAPA SYSTEM TO 2015 36Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 14.7% 2.1% 19.9% 0.0% 12.6% 4.0% 0.0% 8.0% 0.0% 1.5% 1.8% 2.1% 7.4% 2.1% 3.1% 22.0% 7.1% 9.9% 1.1% 2.4% 1.3% 1.1% 6.6% 1.1% 1.5% 3.3% 1.5% 11.5% 0.2% 0.7% 0% 5% 10% 15% 20% 25% 2016 2015
  37. 37. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by CHANGE CONTROL 37Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 19% 3% 21% 1.0%1.3% 7% 4% 1.0% 1.0% 10% 1.0% 1.0% 2% 5% 1.3% 2% 18% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) Agile PLM (Oracle) AutoSHEQ ETQ GMPPro (MOTTO Systems) IQS, Inc. JIRA (Atlassian) MasterControl Qumas (Dassault Systemes) SAP SharePoint (Microsoft) Trackwise (Sparta Systems) Verse ZenQMS Other
  38. 38. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER CHANGE CONTROL VENDORS* Arena Solutions Documentum (EMC) eMatrix/Matrix One PLM (Dassault Systemes) Enovia PLM (Dassault Systemes) ISTM (Remedy) QAD Qualtrax Remedy ARS (BMC) Rescop 38Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  39. 39. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH CHANGE CONTROL SYSTEM 39Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 16.2% 28.9% 11.6% 6.1% 9.7% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 4% 9% 26% 34% 27% Awful Poor Average Good Excellent
  40. 40. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF CHANGE CONTROL SYSTEM 40Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. INSTALLATION IMPLEMENTATION 35.2% 4.2% 8.0% 5.2% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 33.0% 23.1% 1.3% 0.3% 1.0% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  41. 41. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF CHANGE CONTROL SYSTEM TO 2015 41Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 19.0% 3.0% 21.0% 1.0% 0.3% 7.0% 4.0% 10.0% 0.0% 1.0% 2.0% 5.0% 1.3% 2.0% 23.6% 7.0% 10.6% 3.0% 1.3% 1.3% 1.3% 7.0% 1.5% 3.0% 2.6% 10.0% 0.2% 0.7% 0% 5% 10% 15% 20% 25% 2016 2015
  42. 42. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPLAINTS - PRODUCT QUALITY 42Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 17.2% 5.7% 1.1% 23.7% 1.5% 9.2% 4.6% 1.1% 1.9% 6.5% 1.1% 1.1% 3.8% 1.9% 4.6% 1.9% 2.3% 10.7% Manual / Microsoft Office Custom/Internally Developed 123Compliance (Sparta Systems) ACE (PSC Software) AutoSHEQ ETQ GMPPro (MOTTO Systems) IQS, Inc. JIRA (Atlassian) MasterControl Microsoft Dynamics Pilgrim Salesforce SAP Trackwise (Sparta Systems) Verse ZenQMS Other
  43. 43. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER PRODUCT QUALITY COMPLAINTS VENDORS* Aris Global ComplianceQuest isoTracker (Lenox Hill Ltd.) NetRegulus (PTC) Q-Pulse (Ideagen Plc.) SharePoint (Microsoft) Velocity Software Windchill Quality Suite (PTC) 43Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  44. 44. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH PRODUCT QUALITY COMPLAINTS SYSTEM 44Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. TIME SATISFACTION 4% 9% 26% 34% 27% Awful Poor Average Good Excellent 11.4% 21.6% 8.1% 5.1% 7.0% < 1 year 1-3 years 4-6 years 7-9 years > 10 years
  45. 45. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 2.2% 6.2% 4.0% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant INSTALLATION & IMPLEMENTATION OF PRODUCT QUALITY COMPLAINTS SYSTEM 45Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. INSTALLATION IMPLEMENTATION 2.8% 0.3%1.4% Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  46. 46. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF PRODUCT QUALITY COMPLAINTS SYSTEM TO 2015 46Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 19.0% 3.0% 21.0% 1.0% 0.3% 7.0% 4.0% 10.0% 0.0% 1.0% 2.0% 5.0% 1.3% 2.0% 23.6% 7.0% 10.6% 3.0% 1.3% 1.3% 1.3% 7.0% 1.5% 3.0% 2.6% 10.0% 0.2% 0.7% 0% 5% 10% 15% 20% 25% 2016 2015
  47. 47. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPLAINTS - ADVERSE EVENTS 47Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 6.2% 24.2%2.8% 1.7% 9.0% 9.6% 1.7% 5.1% 1.7% 2.2% 11.2% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) Argus (Oracle) Aris Global ETQ MasterControl Pilgrim Trackwise (Sparta Systems) Verse ZenQMS Other
  48. 48. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER COMPLAINTS - ADVERSE EVENTS VENDORS* 123Compliance (Sparta Systems) ComplianceQuest Safefood 360 Tip Technologies 48Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  49. 49. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH ADVERSE EVENTS SYSTEM 49Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. TIME SATISFACTION 11.4% 21.6% 8.1% 5.1% 7.0% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 2% 10% 28% 33% 27% Awful Poor Average Good Excellent
  50. 50. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION IMPLEMENTATION INSTALLATION & IMPLEMENTATION OF ADVERSE EVENTS SYSTEM 50Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 31.0% 1.4% 0.4% 2.5% Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider 32.5%4.3% 7.6% 6.5% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant
  51. 51. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF ADVERSE EVENTS TO 2015 Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 51 18.9% 4.7% 18.5% 1.8% 1.3% 6.9% 0.0% 7.3% 1.3% 0.0% 0.0% 0.0% 3.9% 1.3% 1.7% 21.8% 8.7% 10.8% 1.5% 0.2% 1.2% 1.4% 5.2% 1.0% 2.1% 3.3% 2.3% 8.3% 0.2% 1.0% 0% 5% 10% 15% 20% 25% 2016 2015
  52. 52. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 52 SectionSponsoredBy Are you a Vendor that is not listed in this Report? Fill out your Profile for 2017 NOW! Using a system not listed in this Report? Tell your Vendor!
  53. 53. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by DEVIATIONS AND NON-CONFORMANCES 53Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 19.4% 4.0% 23.4% 1.1%1.1% 8.6% 4.0% 1.4% 8.6% 1.1% 1.1% 2.5% 1.8% 5.8% 1.8% 2.2% 12.2% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) AutoSHEQ Cebos ETQ GMPPro (MOTTO Systems) IQS, Inc. MasterControl Pilgrim Q-Pulse (Gael) SAP SharePoint (Microsoft) Trackwise (Sparta Systems) Verse ZenQMS Other
  54. 54. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER DEVIATIONS AND NON- CONFORMANCES VENDORS* Agile PLM (Oracle) Arena Solutions Blue Mountain CAMA Software ComplianceQuest Enovia PLM (Dassault Systemes) JIRA (Atlassian) Lotus Notes Montium Oracle QMSrs Ltd Qumas (Dassault Systemes) Redmine Rescop ServiceNow TeamPage (Traction Software) uniPoint Software 54Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  55. 55. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH DEVIATIONS AND NON-CONFORMANCES SYSTEM 55Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 16.2% 33.1% 14.3% 4.5% 10.2% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 4% 11% 24% 33% 28% Awful Poor Average Good Excellent
  56. 56. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION IMPLEMENTATION INSTALLATION & IMPLEMENTATION OF DEVIATIONS/NON-CONFORMANCES SYSTEM 56Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 35.0% 4.5% 7.9% 6.0% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 33.8% 1.5%0.4%0.8% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  57. 57. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF DEVIATIONS AND NON- CONFORMANCES TO 2015 57Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 17.9% 3.7% 21.6% 1.0% 8.0% 3.7% 1.3% 8.0% 1.0% 2.3% 1.7% 5.3% 1.7% 2.0% 23.9% 8.7% 10.7% 1.4% 2.4% 1.6% 0.4% 7.1% 1.6% 3.4% 1.8% 10.1% 0.2% 0.8% 0% 5% 10% 15% 20% 25% 30% 2016 2015
  58. 58. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 58 SectionCo-SponsoredBy SectionCo-SponsoredBy
  59. 59. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by DOCUMENT MANAGEMENT 59Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 13.0% 2.0% 24.6% 1.3% 2.7% 8.0% 1.0% 4.3% 1.3% 15.9% 1.0% 1.0% 5.0% 2.0% 4.0% 13.0% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) Cebos Documentum (EMC) ETQ FirstDoc (CSC) GMPPro (MOTTO Systems) IQS, Inc. MasterControl Qumas (Dassault Systemes) SAP SharePoint (Microsoft) Verse ZenQMS Other
  60. 60. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER DOCUMENT MANAGEMENT VENDORS* 123Compliance Agile PLM (Oracle) Arena Solutions AutoSHEQ ComplianceQuest eDOCS (OpenText) Empower PLM (Omnify Software) Formpipe.GxP (Formpipe Software AB) JIRA (Atlassian) Liquent Lotus Notes Montium NextDocs Pilgrim Quality Solutions Q-Pulse (Gael) Rescop TeamPage (Traction Software) TRIM Records Management (HP) uniPoint Software Veeva 60Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  61. 61. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH DOCUMENT MANAGEMENT 61Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. TIME SATISFACTION 22.3% 35.2% 10.6% 5.7% 13.6% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 2% 7% 23% 34% 34% Awful Poor Average Good Excellent
  62. 62. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF DOCUMENT MANAGEMENT SYSTEM 62Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. INSTALLATION IMPLEMENTATION 17.6%2.3% 4.6% 3.1% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 28.8% 46.2% 1.1% 1.9% 1.1% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  63. 63. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF DOCUMENT MANAGEMENT SYSTEM TO 2015 63Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 12.7% 2.0% 24.1% 0.3% 1.3% 2.6% 7.8% 4.2% 0.0% 0.0% 1.3% 15.6% 0.7% 1.0% 1.0% 4.9% 2.0% 3.9% 18.4% 6.8% 16.6% 2.6% 0.6% 6.0% 1.4% 1.2% 1.4% 1.4% 0.2% 12.4% 1.8% 1.2% 2.0% 7.4% 0.0% 0.8% 0% 5% 10% 15% 20% 25% 30% 2016 2015
  64. 64. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by ENVIRONMENTAL HEALTH & SAFETY (EHS) 64Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 30.4% 5.4% 34.5% 8.1% 2.7% 2.0% 16.9% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) ETQ SAP SharePoint Other
  65. 65. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER ENVIRONMENTAL HEALTH & SAFETY (EHS) VENDORS* Blue Mountain DataPipe (Knorr Associates) ecoLOGIC Systems Entropy (BSI) HAZMIN (Logical Technology) KMI MSDSonline QPR Software PLC SFS Chemical Safety 65Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  66. 66. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH ENVIRONMENTAL HEALTH & SAFETY (EHS) SYSTEM 66Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 9.2% 18.4% 3.4% 3.1% 7.3% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 3% 9% 33% 27% 29% Awful Poor Average Good Excellent
  67. 67. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 17.6%2.3% 4.6% 3.1% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant INSTALLATION IMPLEMENTATION INSTALLATION & IMPLEMENTATION OF ENVIRONMENTAL HEALTH & SAFETY (EHS) SYSTEM 67Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 24.5% 11.9% 0.4% 0.4% 0.4% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  68. 68. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF ENVIRONMENTAL HEALTH & SAFETY (EHS) TO 2015 68Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 20.0% 3.6% 22.7% 5.3% 0.4% 1.8% 1.3% 19.8% 5.6% 9.9% 0.6% 0.8% 1.2% 0.0% 0% 5% 10% 15% 20% 25% 2016 2015
  69. 69. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LABORATORY MANAGEMENT (LIMS, ELN, ETC.) 69Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 24.7% 8.6% 4.3% 4.3% 11.8% 6.5% 2.2% 3.2% 5.4% 4.3% 2.2% 22.6% Manual / Microsoft Office Custom/Internally Developed Agilent Empower (Waters Corp.) GMPPro (MOTTO Systems) LabWare (Waters) Lims1 (Ltech Australia Pty Ltd) SAP SQL*LIMS Star LIMS Thermo Scientific Other
  70. 70. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER LABORATORY MANAGEMENT VENDORS* Apollo LIMS (Common Cents Systems) Blaze LIMS (Blaze Systems) Clinsys Group CORE LIMS (Core Informatics) Labtronic / LABWORKS (PerkinElmer) Rescop 70Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. * Those software vendors with less than a 1% response are not reflected in the chart but are included in this list of other Vendors.
  71. 71. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH LABORATORY MANAGEMENT SYSTEM 71Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 3.8% 10.4% 1.9% 2.7% 6.9% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 13% 27% 45% 12% Poor Average Good Excellent
  72. 72. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION IMPLEMENTATION INSTALLATION & IMPLEMENTATION OF LABORATORY MANAGEMENT SYSTEM 72Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 17.6%2.3% 4.6% 3.1% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 24.5% 11.9% 0.4% 0.4% 0.4% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  73. 73. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF LABORATORY MANAGEMENT TO 2015 73Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 13.7% 4.8% 2.4% 0.6% 0.6% 2.4% 6.5% 0.6% 3.6% 1.2% 1.8% 3.0% 2.4% 1.2% 13.6% 4.9% 1.4% 0.4% 0.2% 0.2% 1.8% 0.6% 3.4% 1.0% 4.9% 3.8% 2.0% 1.4% 0% 2% 4% 6% 8% 10% 12% 14% 16% 2016 2015
  74. 74. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by MANUFACTURING EXECUTION SYSTEM (MES) 74Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 18.7% 8.8% 2.2% 1.1% 4.4% 3.3% 2.2% 2.2% 3.3% 2.2% 9.9% 41.8% Manual / Microsoft Office) Custom/Internally Developed Apriso (Dassault Systemes) Camstar (Siemens) Epicor Infor Oracle QAD Rockwell SAGE SAP Other
  75. 75. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER MANUFACTURING EXECUTION SYSTEM VENDORS* IBS US JDA MAPEX Software Navision (Microsoft) NetSuite SharePoint (Microsoft) Werum Software & Systems Wonderware (Invensys / Schneider Electric) 75Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  76. 76. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH MANUFACTURING EXECUTION SYSTEM 76Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 2.3% 7.3% 2.7% 2.7% 12.0% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 3% 13% 44% 37% 4% Awful Poor Average Good Excellent
  77. 77. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION IMPLEMENTATION INSTALLATION & IMPLEMENTATION OF MANUFACTURING EXECUTION SYSTEM 77Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 16.6% 1.5% 1.9% 0.0% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 11.6% 11.2% 1.2% 0.0% 0.8% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  78. 78. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF MANUFACTURING EXECUTION SYSTEM TO 2015 78Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 10.2% 4.8% 1.2% 0.6% 2.4% 1.8% 1.2% 1.2% 1.8% 1.2% 5.4% 0.6% 0.0% 9.3% 6.7% 0.2% 1.0% 0.4% 1.0% 2.6% 0.6% 1.0% 0.2% 8.3% 1.0% 1.0% 0% 2% 4% 6% 8% 10% 12% 2016 2015
  79. 79. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SECTION SPONSORED BY 79Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns.
  80. 80. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by PRODUCT LIFECYCLE MANAGEMENT (PLM) 80Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 25.9% 9.9% 4.9% 3.7% 1.2%1.2% 3.7% 13.6% 1.2% 18.5% 8.6% 1.2% 1.2% 4.9% Manual / Microsoft Office Custom/Internally Developed Agile PLM (Oracle) Arena PLM eMatrix/Matrix One (Dassault) Enovia PLM (Dassault Systemes) ETQ, Inc. GMPPro (MOTTO Systems) OnePlace (Eclipse Computing) PSC Software SAP Siemens PLM Windchill PLM (PTC) Other
  81. 81. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH PRODUCT LIFECYCLE MANAGEMENT SYSTEM 81Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 4.3% 13.6% 1.2% 6.2% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 1% 8% 36% 29% 26% Awful Poor Average Good Excellent
  82. 82. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF PRODUCT LIFECYCLE MANAGEMENT SYSTEM 82Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. INSTALLATION IMPLEMENTATION 14.3% 1.6% 3.1% 1.6% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 12.8% 11.2% 1.2% 0.0% 0.0% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  83. 83. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF PRODUCT LIFECYCLE MANAGEMENT TO 2015 83Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 12.6% 4.8% 2.4% 1.8% 1.8% 6.6% 9.0% 4.2% 0.6% 0.6% 0.6% 0.6% 0.6% 0.0% 10.6% 5.9% 6.7% 0.4% 0.0% 1.4% 0.0% 6.1% 0.6% 0.2% 0.2% 1.4% 1.4% 1.2% 0% 2% 4% 6% 8% 10% 12% 14% 2016 2015
  84. 84. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by STATISTICAL PROCESS CONTROL (SPC) / PROCESS ANALYTICAL TECHNOLOGY (PAT) 84Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 24.8% 5.3% 0.9% 8.0% 2.7% 0.9% 14.2% 26.5% 0.9% 12.4% Manual / Microsoft Office Custom/Internally Developed Cebos GMPPro (MOTTO Systems) Infinity QS ISP Software Solutions Microsoft Excel* Minitab Northwest Analytics (NWA) PQ Systems SIMATIC (Siemens) Synergy (Zontec) WinSPC (DataNet Quality Systems) Other *Due to analytical capabilities in MS Excel, this has been extracted from Manual/MS Office into a specific response. All
  85. 85. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH SPC/PAT SYSTEM 85Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 2.7% 10.5% 7.0% 2.3% 8.2% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 11% 9% 32% Awful Poor Average Good Excellent
  86. 86. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF SPC/PAT 86Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. INSTALLATION IMPLEMENTATION 21.9% 1.6% 1.2% 0.4% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 7.8% 0.4%0.4%0.0% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  87. 87. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF SPC/PAT TO 2015 87Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 13.6% 2.9% 4.4% 1.5% 7.8% 14.6% 0.5% 0.5% 6.7% 3.1% 0.0% 1.4% 3.5% 5.5% 0.8% 0.6% 0% 2% 4% 6% 8% 10% 12% 14% 16% 2016 2015
  88. 88. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SUPPLIER QUALITY 88Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 26.4% 2.8% 25.9%7.5% 5.7% 1.4% 5.2% 4.2% 2.4% 4.2% 1.4% 2.8% 9.9% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) ETQ GMPPro (MOTTO Systems) IQS, Inc. MasterControl SAP SharePoint (Microsoft) Trackwise (Sparta Systems) Verse ZenQMS Other
  89. 89. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER SUPPLIER QUALITY VENDORS* Ariba AutoSHEQ (Centurion Quality Management) ComplianceQuest Documentum (EMC) Infor IQRC Muddy Boots Software Oracle Pilgrim Quality Solutions QAD Q-Pulse (Gael) 89Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  90. 90. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH SUPPLIER QUALITY 90Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 15.2% 27.3% 7.8% 3.5% 10.5% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 4% 8% 33% 28% 27% Awful Poor Average Good Excellent
  91. 91. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF SUPPLIER QUALITY 91Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. INSTALLATION IMPLEMENTATION 28.5% 2.7% 6.6% 5.1% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 30.5% 25.4% 0.4% 0.8% 0.0% Totally Internal Worked with Software Vendor Used a local service provide Used boutique service provider Used top IT service provider
  92. 92. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF SUPPLIER QUALITY TO 2015 92Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 25.5% 2.7% 25.0% 7.3% 5.5% 0.0% 1.4% 5.0% 1.1% 1.1% 1.1% 1.1% 4.1% 2.3% 4.1% 1.4% 2.7% 28.1% 8.6% 11.5% 1.4% 1.2% 1.0% 0.2% 3.9% 0.0% 1.0% 0.4% 1.4% 4.9% 0.2% 3.1% 0.0% 1.0% 0% 5% 10% 15% 20% 25% 30% 2016 2015
  93. 93. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TRAINING/LEARNING MANAGEMENT 93Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix. 14.4% 2.7% 25.9% 1.9% 1.5% 6.1%4.2% 1.1% 2.7% 13.3% 1.5% 1.5% 2.3% 1.5% 4.6% 14.8% Manual / Microsoft Office Custom/Internally Developed ACE (PSC Software) ComplianceWire (UL Eduneering) Cornerstone OnDemand ETQ GMPPro (MOTTO Systems) IQS, Inc. IsoTrain (Softek) MasterControl Saba SharePoint (Microsoft) SuccessFactors (SAP) Verse ZenQMS Other
  94. 94. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by LIST OF OTHER TRAINING/LEARNING MANAGEMENT VENDORS* 123Compliance AutoSHEQ Cebos ComplianceQuest Halogen Software NextDocs PeopleSoft (Oracle) Pilgrim Plateau (SAP) Qumas (Dassault Systemes) Rescop SumTotal Taleo (Oracle) Trackwise (Sparta Systems) uniPoint Software 94Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. * Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.
  95. 95. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by TIME & SATISFACTION WITH TRAINING/LEARNING MANAGEMENT SYSTEM 95Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. TIME SATISFACTION 19.3% 35.0% 11.8% 4.3% 8.3% < 1 year 1-3 years 4-6 years 7-9 years > 10 years 6% 10% 26% 32% 25% Awful Poor Average Good Excellent
  96. 96. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INSTALLATION & IMPLEMENTATION OF TRAINING/LEARNING MANAGEMENT SYSTEM 96Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. INSTALLATION IMPLEMENTATION 30.3% 7.5% 9.1% 7.5% On-Premise 3rd Party Hosted Cloud/SaaS Single Tenant Cloud/SaaS Multiple Tenant 29.1% 38.6% 1.6% 1.2% 0.8% Totally Internal Worked with Software Vendor Used a local service provider Used boutique service provider Used top IT service provider
  97. 97. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by INTEGRATION OF TRAINING/LMS WITH QUALITY OR DOCUMENT MANAGEMENT SYSTEM 97Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% Other Manually extract data from our Quality or Document Management System and enter it again into the Training/LMS System Quality or Document Management System is electronically integrated with our Training/LMS System Training Compliance is part of the Quality or Document Management System functionality 2.4% 11.8% 20.1% 28.3%
  98. 98. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF TRAINING/LEARNING TO 2015 98Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 14.2% 2.6% 25.4% 1.9% 1.5% 6.0% 4.1% 1.1% 2.6% 13.1% 0.4% 0.7% 0.0% 1.5% 1.5% 2.2% 0.4% 1.5% 4.5% 20.7% 10.4% 12.4% 3.5% 0.6% 1.2% 0.2% 0.2% 1.7% 8.7% 1.0% 1.9% 1.5% 1.0% 0.2% 2.1% 1.0% 0.4% 0.8% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 2016 2015
  99. 99. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SAAS / CLOUD BASED SYSTEMS 99Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. What percent of your systems are currently cloud based (or SaaS) or planned to be within the next year? 14.1% 6.4% 7.6% 6.8% 8.8% 5.2% Less than 10% Between 11-25% Between 26-50% Between 51-75% Between 76-99% 100% are Cloud based
  100. 100. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by COMPARISON OF CLOUD (SAAS) SYSTEMS TO 2015 Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 100 9.2% 14.1% 6.4% 7.6% 6.8% 8.8% 5.2% 21.8% 14.0% 7.8% 5.1% 7.4% 7.6% 8.5% 0% 5% 10% 15% 20% 25% 2016 2015
  101. 101. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SOME SELECTED THOUGHTS TO THE TREND OF QMS SOFTWARE MOVING TO THE CLOUD “Easy access, security concerns, private cloud preferred” “Some people are stuck against it. If you pick your partners correctly, it can be such a positive change” “Uptime statistics are interesting, but more important is how often they update the software, do they have an organized/compliant process to do so and do they have a help desk that answers questions in minutes or hours” “Great option for small companies, but the costs really add up” “Only concern is ability to access tables to help define custom queries” “The speed on interaction with application” “Managing change control risk is a challenge” “Takes the burden of data backup systems away and makes life easier for IT” “I prefer this movement provided that the vendor has a firm grasp on software compliance needs” “From a quality perspective I do not mind where a service is hosted so long as it can be qualified” “Cloud based system qualification is new and complex. GAMP or FDA do not have very specific guidelines for cloud based software as yet” “Makes a lot of sense in terms of accessibility and hardware costs. Customer service is very important to the system running effectively” “Cloud only means another companies servers. Security is still an issue, as is encryption” “For our company, cloud is the only way to go. We have limited IT resources. We also want all users to be able to use the system at the same time. Evaluating potential additional usage of cloud computing but moving cautiously” “Current management is opposed to it” “It is an excellent concept that works!” “Risks involved in security of intellectual property are a big concern” “Security restriction and risk is high for our data types” Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 101
  102. 102. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by BIGGEST CHALLENGE IN IMPLEMENTING QMS 102Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 2.0% 2.4% 2.4% 4.0% 5.6% 8.0% 9.2% 9.2% 9.6% 11.2% 12.0% 14.5% 14.9% 18.1% 18.9% 21.7% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% Difficulty in rolling out to many locations world-wide Did not define lean process before automating Data Management (master, transactional, archived) Governance and Change Control Customize too much instead of utilizing out of the box functionality Integration with company's internal systems Difficult to configure Lack of focus from the company (not a priority) Lack of IT support or IT resource availability during implementation Lack of business resource availability during implementation Validation Requirements harmonization across all Business Units Cost of implementation Finding the right Vendor Cost of licenses / subscription Cultural adoption (i.e., not user-friendly, manual to electronic, legacy to new system, individual vs. harmonized requirements) What else? • Acceptance • Data migration • Upgrades cause more issues • Working with systems vendor preferred supplier • Security and encryption • Lack of keeping up with latest versions • Duration • Training and support for remote users • Company politics
  103. 103. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by BIGGEST TECHNOLOGY TREND IMPACTING QMS 103Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 3D Printing Internet of Things (IoT) Intelligent Automation / Smart Machines Other Information of Everything Big Data Analytics Digital Transformation Mobility What else? • Cloud • Electronic batch records • Serialization of pharma products • Electronic archiving • Security
  104. 104. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by RESOURCE SKILLS NEEDED FOR QMS SYSTEMS FUTURE SUCCESS 104Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. With the change of baby-boomers leaving prominent Quality jobs and Millenials coming on-board eager to drive to a new standard, some skills need to be kept at a premium level. Although some of baby-boomers still need better computer skills, this won’t be a problem for Millenials growing up in the age of computers, tablets, smart phones and the internet. Some of the skills needed is not a surprise as these exist today: business process/products and regulatory requirements for Quality, Lean Six Sigma to keep operations efficient without additional cost. But most of all are resources that can be change agents and cultural adoption leaders to help the organization adopt and embrace the new technologies that are affecting Quality now and in the future. Good trainers who know how to train will be needed to be coupled with business SMEs making sure that the investment in rolling out of new system is being understood and used properly. With new technology, companies will need resources who are critical thinkers and have the ability to correctly recognize, prioritize and control risk. Lastly, with all the technology changes, IT needs a closer relationship with quality / business by having the technical know-how but with business acumen. • Business Process Engineering • Training, Certified Trainers and Communication • Data Management • Computer Literacy • Lean Six Sigma • World-wide regulatory knowledge in manufacturing, supply and post-market surveillance • System Admin skills beyond one person • Change Agents, Cultural Adoption Leaders • Risk Assessment and Impact • Technical Know-How with Business Acumen • Compliance Literacy • Business Analysts with Critical Thinking to Recognize, Prioritize and Control Risk • Validation • Facilitation across IT and business and across various business units • Dedicated team for implementations and updates • Facilitate standardization across entire enterprise
  105. 105. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by SELECTED PARTICIPANT’S COMMENTS IN GENERAL “Much needed in our world of metrics” “Have external auditors use ONE system” “Managing the validation and qualification aspect of the implementation is key” “The cultural change going from a paper-based to an electronic QMS is the toughest part of implementation” “FDA is slow to adopt new technologies” “Once working properly, they have saved us so much time now” “Continuous usage gives us long term benefits to the company” “Electronic version should be mandatory” “Always lean before you automate, begin with the end in mind - define what do you want delivered from the system (reports, metrics, etc.)” “Real time data is more and more the trend” “Provide comprehensive training to everyone” “Need a standardized approach to validation within industry” 105Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns.
  106. 106. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by RECOMMENDATIONS FOR 2017 SURVEY • Risk Management (new) • Electronic Batch / DHR Records (new) • Add Customer Service related question(s) to each category • Validation (new) and add related questions to each category • Add Mobility related questions to each category • Which regulations have the most impact to QMS software* • Add Security and privacy of data related questions to each category • IoT* If you have other ideas for next year’s survey, please take our very quick Survey on Ideas Now! Thanks. Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 106 * Will take this under consideration but difficult when going across multiple industries or complex ideas.
  107. 107. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. 107 GoldSponsor GoldSponsor
  108. 108. 108Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.
  109. 109. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 109Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Arena Solutions 989 E. Hillsdale Blvd, Suite 250 Foster City, CA 94404 USA Arena invented cloud PLM. Its holistic suite of PLM, supply chain and QMS solutions enables innovative OEMs with complex electronics to manage their BOMs, facilitate engineering change orders and speed prototyping to improve margins and collapse time to market. Arena has been ranked a Top 10 PLM provider and won the coveted Design News Golden Mousetrap Award in 2016. Contact: Umesh Malhotra E-Mail: sales@arenasolutions.com Phone: +1 877 937 1433 Website: www.arenasolutions.com Facts: Number of employees: 51-200 Years in Business, Since: 2000 Annual Revenue: Privately Held Geographic Regions: All Primary Industries: Automotive, Biotechnology, Computer Hardware, Software, Networking, Consumer Electronics, Goods, Services, Electrical & Electronic Manufacturing, Industrial Automation, Machinery, Medical Device, Oil, Gas, Renewables & Energy, Pharmaceuticals, Plastics, Railroad Manufacturing, Semiconductors, Telecommunications, Transportation/Trucking/Railroad Solutions Offered: Adverse Events, Audit Management (Internal/External), Calibration & Maintenance, Management, CAPA Management, Change Control Management, Complaints (Product Quality, Technical), Document Management, EHS (Environmental, Health & Safety) Management, Exception Management (deviations, nonconformances), Laboratory Management, PLM, SPC/PAT, Supplier Quality Management, Training Management Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: Cloud/SaaS Multi-Tenant Cognizant MedVantage 6330 South 3000 East, Suite 200 Salt Lake City, Utah 84121 MedVantage from Cognizant, is a cloud-based solution for Medical Device Enterprise- built on Force.com and Service Cloud Platform that helps Medical device Industry for seamless Product Recall/Repair Management Process and ensures regulatory compliance (GxP, CAPA, FDA 3500A Med Watch, 21 CFR 820, 821 and Part 803) and Post installation field services management. Contact: GowriShankar Vembu E-Mail: GowriShankar.Vembu@cognizant.com Phone: +1 408 306 7130 Website: www.cognizant.com/medvantageercontrol.com Facts: Number of employees: 5000+ Years in Business, Since: 1994 Annual Revenue: 1B+ Geographic Regions: Asia Pac, Europe, Middle East, North America Primary Industries: Medical Device Solutions Offered: Adverse Events, CAPA, Complaints, Deviations and Nonconformances, Supplier Quality Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: Cloud Multi-tenant Subscription
  110. 110. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by EtQ, Inc. 399 Conklin Street, Suite 208 Farmingdale, NY 11735 USA EtQ's flexible platform has been the foundation for automating critical compliance solutions for over 20 years. Whether you are looking for an enterprise solution, mid-market solution, or you're an individual contributor, EtQ truly has a solution for every company in the world. The result is a set of solutions for all market types residing on a common, proven and strong compliance platform technology. This means that regardless of size, scope, or investment, EtQ has a product for you. Our product family consists of EtQ Reliance for Enterprise, Verse Solutions for SMB, and traqpath - our free compliance event and CAPA tracking app for mobile and Web. Contact: Timothy Lozier E-Mail: info@etq.com Phone: +1 516 293 0949 Website: www.etq.com Facts: Number of employees: 201-500 Years in Business, Since: 1992 Annual Revenue: Privately Held Geographic Regions: All Primary Industries: All Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA, Change Control, Complaints (Product Quality, Technical), Deviations and Nonconformances, Document Management, EHS, PLM, Supplier Quality, Training Certifications: ISO 9001, ISO 27001 Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Single-tenant subscription, Cloud Multi-tenant Subscription 110Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. CyberMetrics - Bronze 1523 W. Whispering Wind Drive, Suite 100 Phoenix, AZ 85085 CyberMetrics Corporation delivers world-class, auditor-recommended software solutions for calibration management and maintenance management that are flexible, scalable and easy to implement, manage and use. Over 12,000 facilities worldwide choose our software solutions to assure standards compliance, maximize efficiency and reduce costs. Contact: Shana Jordan E-Mail: sjordan@cybermetrics.com Phone: 480-371-2333 Website: http://www.cybermetrics.com Facts: Number of employees: 1-50 Years in Business, Since: 1988 Annual Revenue: Privately Held Geographic Regions: All Primary Industries: Automotive, Biotechnology, Chemicals, Consumer Electronics, Goods, Services, Cosmetics, Defense & Space/Military, Electrical & Electronic Manufacturing, Food & Beverages, Gambling & Casinos, Glass, Ceramics, Plastics& Concrete, Hospital & Health Care, Industrial Automation, Machinery, Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy, Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Transportation Solutions Offered: Calibration & Maintenance, Document Management, Supplier Quality Management, Training Certifications: ISO 9001, ISO 13485, ISO/TS 16949, ISO/IEC 17025, AS 9100 Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Single-tenant subscription, Cloud Multi-tenant Subscription, 3rd Party Hosted License
  111. 111. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 111Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Formpipe Life Science 13 Poplars Court Lenton Lane Nottingham N G7 2RR UK The Formpipe Life Science division simplifies complex process and technology environments to deliver customers’ quality and compliance goals within the relevant regulatory framework(s). This is achieved through a combination of Consultancy to ‘Get Compliant’, and Products and Consultancy to ‘Stay Compliant.’ Both are delivered by experts from the sector. A suite of products addresses the compliance and quality needs of Life Science organisations, all of which are designed to be easy to use, increase efficiency and reduce costs across businesses with 50-25,000 users. All Life Science products are managed using a bespoke internal Quality Management System and are supported and maintained by a dedicated global team. The company's software helps improve efficiency, cut costs and reduce risk exposure. Contact: Keith Williams Email: keith.williams@formpipe.com Phone: +44 115 924 8475 Website: www.formpipe.com/lifescience Facts: Number of employees: 201-500 Years in Business, Since: 1997 Annual Revenue: 1-25M Geographic Regions: North America, Europe, Asia Pac Primary Industries: Hospital & Health Care, Information Technology & Services, Medical Device, Pharmaceuticals, Cosmetics, Chemicals, Biotechnology Solutions Offered: Training, Supplier Quality Management, Manufacturing Execution (MES), Laboratory Management (LIMS, LES), Deviations and nonconformances, Document Management, Change Control, CAPA, Audit Are you FDA 21 CFR Part 11/ EU DIR Compliant? Yes License Type: On-Premise (in-house), Cloud (single tenant) Subscription, Cloud (multi-tenant) Subscription MasterControl 6330 South 3000 East, Suite 200 Salt Lake City, Utah 84121 MasterControl Inc. is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl's quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. MasterControl's complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated. Contact: Matt Lowe E-Mail: mlowe@mastercontrol.com Phone: 801-942-4000 Website: www.mastercontrol.com Facts: Number of employees: 201-500 Years in Business, Since: 1993 Annual Revenue: Privately Held Geographic Regions: All Primary Industries: Automotive, Biotechnology, Chemicals, Consumer Electronics, Goods, Services, Electrical & Electronic Manufacturing, Food & Beverages, Hospital & Health Care, Logistics, Warehouse & Supply Chain, Medical Device, Oil/Gas/Renewables & Energy, Pharmaceuticals Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA, Change Control, Complaints, Document Management, EHS, Deviations and Nonconformances, Supplier Quality, Training Certifications: ISO 9001 Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Multi-tenant Subscription
  112. 112. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by Motto Systems PVT LTD - Bronze SAMRIDHI VASYAM, JAI HIND COLONY, MADHAPUR HYDERABAD, TELENGANA 500081 INDIA Motto Systems’ is an organization that has made pioneering strides in providing top-class enterprise quality management solutions (EQMS) to Life Sciences’ companies. GMPPro is a end to end quality compliance tool. Driven by innovation and backed by a qualified team of GMP domain and IT experts. We offer complete Warehouse, Production, QA, QC & Maintenance modules. Contact: K RAJGOPA E-Mail: raj@mottosys.com Phone: +9553444478 Website: www.MottoSys.Com Facts: Number of employees: 1-50 Years in Business, Since: 2012 Annual Revenue: 1-25M Geographic Regions: Asia Pac, Europe, Latin America, Middle East, North America Primary Industries: Chemicals, Food & Beverages, Packaging & Containers, Pharmaceuticals Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control, Complaints, Document Management, Deviations and Nonconformances, Laboratory Management (LIMS, LES), Product Lifecycle (PLM), Supplier Quality Management Certifications: ISO 9001, ISO 27001 Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Single-tenant subscription 112Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Qualio 156 2nd St. San Francisco, CA 94105 USA Qualio helps life-saving technologies get to market faster through making Quality a competitive advantage. A simple dashboard makes it easy to manage all the daily activities for quality teams. Real-time reporting puts you in control so you can be audit ready at all times, and built-in QA/RA best practices makes it easy to build, maintain and scale your quality program. With customers all over the word from early stage medical devices to public biotechnology organizations, Qualio is a perfect partner to help your company scale. And with offices in California, Ireland and Poland – no matter where you are we’ve got you covered. Contact USA: Colin Moore Contact Ireland: Damien Barry E-Mail: info@qualio.com Phone: +1 855 203 2010 USA Phone: +353 1 697 1522 Ireland Website: www.qualio.com Facts: Number of employees: 1-50 Years in Business, Since: 2012 Annual Revenue: Privately Held Geographic Regions: Asia Pac, Europe, North America Primary Industries: Biotechnology, Medical Device, Pharmaceuticals Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical), Deviations and Nonconformances, Document Management, Training Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: Cloud Multi-tenant Subscription
  113. 113. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 113Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. SoftExpert Software 201 South Biscayne Blvd. Suite, 1200 Miami/FL USA SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs. Along with its extensive network of international resellers, SoftExpert also provides hosting, implementation, post-sales support and validation services to ensure that customers realize the maximum value from their investments. E-Mail: sales@softexpert.com Phone: 1-646-504-7910 Website: www.softexpert.com Facts: Number of employees: 201-500 Years in Business, Since: 1995 Annual Revenue: Privately Held Geographic Regions: All Primary Industries: All Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control, Complaints (Product Quality, Technical), Deviations and Nonconformances, Document Management, EHS, Laboratory Management, PLM, SPC/PAT, Supplier Quality, Training Certifications: ISO 9001, ISO 13485, ISO 14000, ISO 27001 Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Single-tenant subscription, Cloud Multi-tenant Subscription, 3rd Party Hosted License Traction Software 245 Waterman St., Suite 504 Providence, RI 02906 Traction TeamPage is collaboration software geared towards addressing a spectrum of ISO related use cases ranging from documentation and management team meetings/reporting to tracking quality issues and executing on improvement projects. Contact: Jordan Frank E-Mail: jfrank@tractionsoftware.com Phone: 1-401-487-2268 Website: www.tractionsoftware.com Facts: Number of employees: 1-50 Years in Business, Since: 1996 Annual Revenue: Privately Held Geographic Regions: Africa, Asia Pac, Europe, North America Primary Industries: Automotive, Banking, Biotechnology, Chemicals, Computer Hardware/Software/Networking, Construction, Consumer Electronics/ Goods/Services, Defense & Space/Military, Electrical & Electronic Manufacturing, Environmental/Facilities Services, Financial Services, Food & Beverages, Hospital & Health Care, Industrial Automation, Information Technology & Services, Logistics/Warehouse & Supply Chain, Medical Device, Mining & Metals, Oil/Gas/Renewables & Energy, Pharmaceuticals, Semiconductors, Wholesale Solutions Offered: Adverse Events, Calibration & Maintenance, CAPA, Change Control, Complaints, Document Management, Deviations and Nonconformances, Training Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: On-Premise, Cloud Single-tenant subscription
  114. 114. *Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns. Sponsored by 114Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved. Want to be a sponsor for the 2017 QMS Vendor Software Benchmark Report? ZenQMS 128 Front Street Conshohocken, PA 18925 USA ZenQMS develops amazing quality management software for the whole enterprise. Our cloud-based platform, which includes modules for Document Management, Issue/CAPA, Training, Audits & Supplier Management, offers companies a tremendous opportunity to improve quality compliance and save money. Contact: Jeff Thomas E-Mail: hello@zenqms.com Phone: +1 888 280 1433 Website: www.ZenQMS.com Facts: Number of employees: 1-50 Years in Business, Since: 2010 Annual Revenue: Privately Held Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North America Primary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverage, Hospital & Healthcare, Medical Device, Pharmaceuticals Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical), Document Management, Training Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES License Type: Cloud Multi-tenant Subscription
  115. 115. 115Quality & Regulatory Network LLC Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.

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