Qualtrax is a web-based software that provides document control, automated workflows, training, and testing to ensure compliance. It supports standards like GFSI and SQF. Mobiltrax is a companion app that allows remote data capture to enhance product quality and visibility through management by exception. Data is captured in the field and deviations are automatically routed. Workflows standardize processes and notifications ensure tasks are completed.
RBI is a proven method to determine the optimum inspection
scope and interval using a risk-based data-driven approach. It
improves equipment integrity, safe operational efficiency, and
maintenance cost of both static pieces of equipment and piping.
Simple and Effective Solution for Equipment Calibration, PM (Preventative Maintenance) and OOT (Out of Tolerance) Management. Use Calibration Management Software for increased productivity and meet the compliance requirements for ISO and FDA.
We have an ISO 17025 calibration laboratory and we provide NABL calibration services worldwide. Visit our website http://bit.ly/2HVkg21 and book your calibration services.
In any kind of manufacturing industry, the calibration of instrument plays a very important role and also it occupies a very significant place. Whenever a product comes into existence, back of it there's a perfect flow calibration. Calibration is a set of operations, which under certain conditions build relationships amongst values indicated by a measuring instrument.
Targeted customers - All organizations who wish to do internal audits, Auditing companies for them to do audit for other companies, Consulting & research oriented companies who wish to do field data collections, Companies / management team who wish to do activity tracking of key initiatives assigned to their teams.
Qualtrax is a small, successful team that places an emphasis on project management and collaboration. This presentation will address some key points that we follow when working on a project.
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.
The 2015 Quality Management System Vendor Benchmark Report is a survey across industries and geographies on IT/Technology systems used today for Quality Management. Survey had 700+ participants worldwide. Comparisons to 2014 Benchmark are also included. A complete Vendor Listing is located in the Appendix.
These ready to use LIMS are designed for versatility, security, accessibility ensuring any time connectivity over
a secure web network interface, cross platform and cross database compatibility with customization
possibilities. Well established research organizations and laboratories choose to implement enterprise edition
of LIMS after a lot of deliberation and for a bunch of good reasons
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
RBI is a proven method to determine the optimum inspection
scope and interval using a risk-based data-driven approach. It
improves equipment integrity, safe operational efficiency, and
maintenance cost of both static pieces of equipment and piping.
Simple and Effective Solution for Equipment Calibration, PM (Preventative Maintenance) and OOT (Out of Tolerance) Management. Use Calibration Management Software for increased productivity and meet the compliance requirements for ISO and FDA.
We have an ISO 17025 calibration laboratory and we provide NABL calibration services worldwide. Visit our website http://bit.ly/2HVkg21 and book your calibration services.
In any kind of manufacturing industry, the calibration of instrument plays a very important role and also it occupies a very significant place. Whenever a product comes into existence, back of it there's a perfect flow calibration. Calibration is a set of operations, which under certain conditions build relationships amongst values indicated by a measuring instrument.
Targeted customers - All organizations who wish to do internal audits, Auditing companies for them to do audit for other companies, Consulting & research oriented companies who wish to do field data collections, Companies / management team who wish to do activity tracking of key initiatives assigned to their teams.
Qualtrax is a small, successful team that places an emphasis on project management and collaboration. This presentation will address some key points that we follow when working on a project.
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.
The 2015 Quality Management System Vendor Benchmark Report is a survey across industries and geographies on IT/Technology systems used today for Quality Management. Survey had 700+ participants worldwide. Comparisons to 2014 Benchmark are also included. A complete Vendor Listing is located in the Appendix.
These ready to use LIMS are designed for versatility, security, accessibility ensuring any time connectivity over
a secure web network interface, cross platform and cross database compatibility with customization
possibilities. Well established research organizations and laboratories choose to implement enterprise edition
of LIMS after a lot of deliberation and for a bunch of good reasons
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Effectively Manage Counterfeit Parts with a Quality SolutionTIP Technologies
Mitigate risk and control counterfeit parts by managing quality within your supply chain. Discover how an effective quality management system can provide supplier approvals, certification, and performance measurements. Parts management provides the ability to track and recall any nonconforming material.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
AmpleLogic Quality Management System (QMS) is a web-based quality management software that provides an end to end solution to the organizations that enables to automate or eliminate paper-based the processes and integrating them across a single platform. This will bring exceptional transparency across all the systems and in resolving your issues down their roots.
AmpleLogic Quality Management System is a web based QMS software that helps organizations to efficiently monitor, manage and meet your quality goals. Our integrated quality management software that handles various modules such as CAPA, Change Control, Deviations, Market Complaints, Document and Training Management, OOS/OOT, Audit and Vendor Management etc. It is specifically designed for highly regulatory industries like Pharmaceutical, Life Sciences, Biotechnology and Healthcare etc.
How QEdge assist you to accelerate your ROI?SarjenSystems
QEdge provide you a single unified platform to streamline and automate your process, people, procedure and documentation for better transparency, control and performance.
Cost and Time savings through ValGenesis -Validation Software SolutionValGenesis
As a pioneer in the development of automated validation software solutions, ValGenesis, Inc. leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time. With years of development and refinement in place,
ValGenesis is the first to offer users real-time paperless validation via electronic execution thereby minimizing ineffectiveness and maximizing efficiency.
ValGenesis automates and manages the validation life cycle and provides real time validation status of any system corporate wide.
Qualityze’s highly configurable and flexible audit management software solution enabling adaptive to various types of audits such as Internal, External, Third Party, Ad-Hoc, Regulatory, Supplier, IT and for organizations to perform regular audits and risk management to ensure product safety and quality.
We provide Audit Management Software with improvd quality, reduce costs involved in preparing for and conducting audits.
Qualityze effectively manages audit management workflow with the following steps
Creating an Audit Plan
Scheduling an Audit
Preparing an Audit
Executing Audit
Track findings
The aim is to be a one stop service provider for consulting and support services related to compliance, validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions catering to clients in the life sciences industry. The main objective is to provide services that enhance current operations and bring the knowledge and experience needed to maintain, manage and control related services.
The philosophy of IVY Works is to be transparent, open and work with our Clients as part of their teams to achieve set objectives and goals.
Experience: Extensive experience among the founders in regulatory compliance, validation, CSV and IT Solutions. All consultants have relevant experiences in the life sciences industries with exposure to the whole gamut of operations (manufacturing, labs, IT, regulatory).
Exposure: Founders and Consultants have worked with a majority of the top ten Pharmaceutical companies in lead roles to manage and also better develop, implement and validate compliance processes. Have worked with clients in North America, Europe & Asia.
Performance: Proven track record of delivering ahead of budget and timelines for a variety of projects/ programs
Delivery: Ability to take on projects of any size – with the same emphasis on project delivery and management
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
2. Overview Provides consistent and accurate documentation across an enterprise Web based Easy to use and implement Secure document control Workflows automate manual processes Training and testing included Flexible searching and reporting
4. Document Management Control document access Track document revisions and editors Provide consistency Ensure compliance
5. Powerful Workflows Automate paper-based processes Qualtrax Inbox keeps items needing attention in one place Notification of tasks via email alerts Maintain separate workflows for each control point All workflow instances are searchable and reportable
7. Mobiltrax Data Capture for Food Safety Handhelds feed Qualtrax Automates remote data capture for CCPs, Quality checks and Audits Enforces behavior Scorecards and Shift Logs help manage by exception CAPAs, etc initiated by out of range data Reduces errors, risk and waste Greatly enhances compliance
18. Handheld Data Entry Monitor enters Green Weight, Pumped Weight and Pickle Temp Monitor submits task for grading and Pump % is calculated “Over the shoulder” verification by Quality Manager in Supervisor Mode
19. Scorecard View scorecard for a particular date using the pop-up calendar Restrict readings based on quality or critical readings Add quality related document links within scorecard Drill down by location and time to view shift logs.
25. Add footer information to shift logs including product specsTasty Foods -> Salem -> Bacon Line 1
26. Preshipment and Record Review Preship review workflow sent to appropriate supervisor by task scheduler Preship reviewer selects the status: Approved, Hold or Discard The preship status is captured in the shift log along with the preship date/time All preship items are sent to the responsible party for record review Tasty Foods -> Salem -> Bacon Line 1
27. Search Tool Conduct searches based on custom fields within workflow View all Belly Product/Pickle Type entered within certain date ranges View all Belly Product/Pickle Type with deviations Direct Links into the workflow instance
28. Reporting Tool Custom design report tool based on workflow fields Link to specific workflow instances ID numbers Save and share report instances through report security Chart creation and exporting options
29. Notifications and Alarms Email actions customized for each state within workflows Email reminders sent at specified time frames Email escalations sent to management Alarm generation can be sent to blackberry and/or phone
30. Qualtrax – Web based, enterprise compliance software for doc control, automated workflow, training and testing; supports GFSI, SQF, BRC, etc. Mobiltrax – Remote data capture extension of Qualtrax that: Enhances product and process quality and visibility Allows management by exception Provides automated deviation routing and escalation
31. 3rd Party Software (SPC, ERPs, SharePoint) Document Control Life Sciences Food Enterprise Interfaces Manufacturing Compliance Management Testing & Training Reporting & Charting Standards-Based Auditing Enforcing Behavior Enhanced Workflows Scorecards File Transfer, Active Directory, and Improved Performance & UI Data Capture Deviation Routing Doc. Compare Module Audits Imaging Module FDA Module Mobile Audit Module Vision
Editor's Notes
Qualtrax is the base product, and Mobiltrax is the remote data capture module. Mobiltrax add handheld capability as well as Scorecard and Shift Log support.
Qualtrax is a full function document management solution that includes a range of features for ensuring regulatory compliance while improving productivity
This will ensure that all employees are always looking at the latest version of a document. All updates and prior versions can be tracked.
Any process that you can flowchart can be developed as a workflow. This creates an efficient, paperless environment. It is important to note that all workflow information is reportable and searchable.
Qualtrax is the base product, and Mobiltrax is the remote data capture module. Mobiltrax add handheld capability as well as Scorecard and Shift Log support.
Mobiltrax is fully integrated with Qualtrax.
We have taken the actual Belly Pump process and added your quality limits to the business rules. It is a fully functioning flow automatically passing tasks to all appropriate users. This method can be duplicated for any of your control points.
This is an actual screen shot of the Belly Pump task sent from Qualtrax to the handheld.
You enter the Scorecard location based on your user authorization. By simply clicking on a box you can drill down to lower locations.The ‘Quality Policy Statement’ line will directly link you to a Qualtrax approved document.
The monitor readings are passed to the PreShip manager based on authorizations. After sign-offs, the verification task is then passed to the Record Review manager. This is an automatic, electronic process.When you link to the deviation reports (eg, CAPA), you are getting the current state of all the text fields. These reports can be passed to multiple people for updates or review.
There are many different ways to access information. This includes not only a range of filter criteria, but also standard and custom reports, as well as advanced search methods.
You can define multiple actions for any process. This means you can notify individuals or groups based on one or more results from the readings. This includes Emails, text messages, and other alarms.