Validation Data Management Systems
“Electronic execution, Validation Data Management, and paperless validation systems”
Have you considered software to manage your CQ&V program? Mangan has had the opportunity to work with several bespoke and commercial validation data management systems throughout the Biopharm industry. Our industry presence has enabled us to experience firsthand the limitations and advantages of these systems and we can leverage this experience to help you implement the system that best fits your needs and work practices.
What are the key features you should expect from a system?
Primarily, the system you choose should be scaleable to fit your organization and your work processes. Beyond that, consideration should be given to the following features:
- Requirement Traceability and Management
- Risk Traceability and Management
- Test Case Library
- Protocol Templates
- Discrepancy/Test Failure Management
- Change Evaluation
- Document Management Features
- Validation History Tracking
- Part 11 / Annex 11 Features
- Offline Execution Capabilities
- Requalification / Periodic Review Scheduling
What can we do?
Mangan Biopharm offers personnel who can provide computer system validation (CSV) support for your systems supporting GxP activities in the heavily-regulated biopharmaceutical Industry. Our collective experience working with validation data management/electronic execution systems can be leveraged to help you evaluate whether one of the available commercial applications is right for your organization.
Why choose Mangan?
After twenty years of providing services to our clients, our personnel have the expertise to work with you on projects of all sizes. Regardless of project scope and size, Mangan Biopharm can provide expert professional services to deliver projects on time and on budget without sacrificing quality.
Requirements Traceability and Management
When evaluating a system, consider whether user and functional requirements can be managed such that traceability to design and testing can be accomplished within the system. A well-developed system will include the ability to link user/functional requirements to cooresponding design elements and test cases allowing the user to quickly identify gaps and develop design qualification and traceability matrix documents.
Risk Traceability and Management
Can the system manage your validation risk assessment process and trace risk elements through design and testing? Not all systems offer this feature, but it is certainly a value-add when offered.
Test Case Library
Depending on your validation program, a repository where you can house pre-approved test cases may be a feature you want to consider. A repository of test cases builds consistency into your CQ&V program and reduces test cases development errors.
Discrepancy / Test Failure Management
How does the system handle testing failures? Do you have to manage failures outside of the validation data system? When test failures occur, you want the capability to quickly issue, approve, and re-execute testing (if necessary) within the validation data system. The system should carry the information from each failure over to your summary reports.
Is data from one document transferable to other documents for the equipment/system/process under test? For example, system description information is typically contained within several lifecycle documents and the ability to complete this information once and utilize for other documents saves time and potential errors.
At its core, a validation data system should have key features associated with a document management system including: version control, review/approval routing, archiving, and document release management.
The system should support lifecycle documents created outside of the validation data system in order to maintain accurate system design, testing information, and a complete validation file.
Are you ready for paperless CQV? If so, a system that has electronic execution capabilities is a key feature to consider. In that regard, the system should support offline execution in those instances when your network is down. Further, be sure to complete a rigorous evaluation of the data integrity and part 11/annex 11 features of the systems you are evaluating. Electronic execution is only valuable if data integrity principles are built into the system.
Requalification/Period Review Scheduling
How are you currently managing requalification/period review schedules? Your asset management system? Joe Q Public’s spreadsheet or calendar? There are multiple ways to tackle your requalification/periodic review schedule, but the ability to manage within your validation data system will help reduce late requalifications and periodic reviews.
When you are asked to pull the CQV history for an asset, how centralized is that information? A good validation data system will have the capability to quickly display the history of changes, periodic reviews, requalifications, and change assessments completed for each system.