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Implementing an Integrated Quality ManagementSystem in SharePointPresented by Jeff ShuranDirector Global Sales & Marketing...
/ SharePoint for Pharma Series • Webinar series that aims to highlight the different aspects of validation   and using Sha...
/ Overview • Quality Challenges in Life Sciences Today • Benefits of an Integrated Approach to Quality • How Quality Syste...
/ Today’s Current Challenges for Quality • Deficiencies in Control of Processes • Deficiencies in the Accountability of Pe...
/ Quality and Compliance Challenges • Meet FDA/EMEA regulations that can only be solved with a centralized   and holistic ...
/ Quality and Compliance Challenges   Regulatory Demands   – Avoid 483s, warning letters, and maintain consistent     comp...
/ Case Study Profile of the client • Mid-sized pharmaceutical company headquartered in the Northeastern   US • Multiple fa...
/ Case Study The state of the environment from a quality perspective • Quality not a main component of company culture • Q...
/ What is the most pragmatic approach to  tackling all of these issues? An Integrated Approach Allows for a Strategic Appr...
/ Case Study Identifying, tracking, and managing quality issues should involve an integrated approach that brings together...
/ Power of Integration •   Accelerate the time for resolution and closure of issues •   Reduce the risk of missing records...
/ Increase Visibility Across The Enterprise    • Increased visibility across the enterprise by alerting the      proper us...
/ Increase Visibility Across The Enterprise    • Proactive approach can reduce the risk of repeating the same      mistake...
/ SharePoint’s Strategic Advantage     Consider the cost of licensing, support, training, and maintenance of              ...
/ SharePoint’s Strategic Advantage     Furthermore and perhaps more importantly, consider the cost of • Users’ frustration...
/ What is SharePoint?   “Microsoft SharePoint makes it easier for people to work together. Using   SharePoint, your people...
/ Why SharePoint?                          SharePoint’s Building Blocks •   Sites – Building and Managing Internal and Ext...
/ Workspaces - Approach Incident Management   Training Audits                Validation Documentation CAPA                ...
/ Quality Workspace Example
/ Lessons LearnedIntegrated Quality System Based on SharePoint•   Increase in Quality and Compliance•   Centralized Qualit...
/ Next Webinar          Announcement Coming Soon           Montrium Webinar Series
/ Contact Details                    Jeff Shuran                   Montrium Inc.           507 Place d’Armes, Suite 1050  ...
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Implementing an Integrated Quality Management System in SharePoint

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Implementing an Integrated Quality Management
System in SharePoint

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Implementing an Integrated Quality Management System in SharePoint

  1. 1. Implementing an Integrated Quality ManagementSystem in SharePointPresented by Jeff ShuranDirector Global Sales & MarketingJanuary 19th, 2012
  2. 2. / SharePoint for Pharma Series • Webinar series that aims to highlight the different aspects of validation and using SharePoint in GxP environments • 4 different sessions covering the different aspects of deployment, use and validation of SharePoint • Should provide attendees with a good grounding for their SharePoint projects • Slides can be distributed upon request. Details on how to request slides will be distributed to attendees following each webinar. • Thank you for your interest!
  3. 3. / Overview • Quality Challenges in Life Sciences Today • Benefits of an Integrated Approach to Quality • How Quality Systems Should be Positioned at the Center of your Processes • Why SharePoint? • How information can be leveraged to make business decisions • Examples of an Integrated Quality Management System • Lessons Learned • Upcoming Webinars
  4. 4. / Today’s Current Challenges for Quality • Deficiencies in Control of Processes • Deficiencies in the Accountability of People • Deficiencies in the Visibility of Data
  5. 5. / Quality and Compliance Challenges • Meet FDA/EMEA regulations that can only be solved with a centralized and holistic approach to quality • Securely identify, track and manage many disparate processes • Guarantee reliable and current information needed to make proper business decisions • Proactively rather than reactively identify product issues and problems
  6. 6. / Quality and Compliance Challenges Regulatory Demands – Avoid 483s, warning letters, and maintain consistent compliance (i.e. GxP , 21 CFR Part 11, other FDA/EMEA regulations) – Alleviate and lessen the risk of stopping production – Shorten process timelines by closing issues faster and more accurately
  7. 7. / Case Study Profile of the client • Mid-sized pharmaceutical company headquartered in the Northeastern US • Multiple facilities • Contacted Montrium regarding implementing a Global Quality Management System
  8. 8. / Case Study The state of the environment from a quality perspective • Quality not a main component of company culture • Quality was an afterthought Thus • Quality was very decentralized • Islands of data and processes existed
  9. 9. / What is the most pragmatic approach to tackling all of these issues? An Integrated Approach Allows for a Strategic Approach and Benefits • Customer Service • Regulatory Affairs • Manufacturing • Laboratory and Production • Department Managers • Assigned Parties • Executives
  10. 10. / Case Study Identifying, tracking, and managing quality issues should involve an integrated approach that brings together the following entities: • Manufacturing • Research and Development • Regulatory Affairs • Quality Assurance • Quality Control • Drug Safety • Other Areas
  11. 11. / Power of Integration • Accelerate the time for resolution and closure of issues • Reduce the risk of missing records and data • Spend time on value added activities instead of non-value activities • Reduce the risk of error through entering in data multiple times • Allows the ability to see across the enterprise and utilize this data for metrics and trending
  12. 12. / Increase Visibility Across The Enterprise • Increased visibility across the enterprise by alerting the proper users about what due dates are and escalating any late issues • Increase responsiveness to issues that may arise • Elimination of errors and repeat issues by centralizing quality processes • Preclude product recalls
  13. 13. / Increase Visibility Across The Enterprise • Proactive approach can reduce the risk of repeating the same mistakes in the future • Keep a positive brand image • Reduce the legal risks
  14. 14. / SharePoint’s Strategic Advantage Consider the cost of licensing, support, training, and maintenance of various tools like • Content Management Systems • Document Management Systems • Reporting Tools • Collaboration Tools
  15. 15. / SharePoint’s Strategic Advantage Furthermore and perhaps more importantly, consider the cost of • Users’ frustration over multiple tools • Management not being able to get their arms around and extract organization information • Relevant information is not available when needed
  16. 16. / What is SharePoint? “Microsoft SharePoint makes it easier for people to work together. Using SharePoint, your people can set up Web sites to share information with others, manage documents from start to finish, and publish reports to help everyone make better decisions” - http://sharepoint.microsoft.com/en-us/Pages/default.aspx
  17. 17. / Why SharePoint? SharePoint’s Building Blocks • Sites – Building and Managing Internal and External Websites • Communities – Creating a Collaboration Environment • Content – Manage Your Documents, Data, and Records • Search – Leverage your Organization’s Data • Insights – Mining for Business Intelligence • Composites – No code solutions to rapidly respond to business needs
  18. 18. / Workspaces - Approach Incident Management Training Audits Validation Documentation CAPA Change Management Change Control SOP Management Batch Records Supplier Quality
  19. 19. / Quality Workspace Example
  20. 20. / Lessons LearnedIntegrated Quality System Based on SharePoint• Increase in Quality and Compliance• Centralized Quality Processes• Manage and Meet External and Internal Regulatory Requirements• Greater visibility into Issues• Take a Proactive Approach Through Trending• Lower Cost of Ownership (i.e. Validation, Upgrades, Integration)
  21. 21. / Next Webinar Announcement Coming Soon Montrium Webinar Series
  22. 22. / Contact Details Jeff Shuran Montrium Inc. 507 Place d’Armes, Suite 1050 Montreal (QC) H2Y 2W8 Canada Tel. 514-223-9153 ext.219 jshuran@montrium.com www.montrium.com

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