In this series we will explore the documentation required to successfully deliver and record a Computer System Validation (CSV) project.
For GxP systems it is necessary to establish a series of documentation to record the approach and execution of validation. The documents in this series are based on a GAMP5 approach to a Category 4 – Configured Product.
In larger projects, the design review is crucial in ensuring the design and configuration of a system meets the User Requirements. The design review is often completed in parallel with the Requirements Traceability Matrix (RTM) and involves assessing design and configuration specifications to provide traceability back to your requirements. The design review report (the outcome of the Design Review activity) reports on the current system design and provides a baseline on which to validate. The report will reference the RTM and will identify any areas of the system/equipment which have not been appropriately designed or configured to meet the users requirements. These findings will be assessed and actions defined to remediate the areas of concern.
Design review actions usually follow 2 paths, either the design/configuration needs adjustment, or the requirements need updating. All actions defined in the Design Review Report must be captured in a project change control and assessed for impact to the project.
The design review report can be used as a project milestone prior to the commencement of testing activities. The Design Review Activity and report should be updated whenever the design or configuration of the system is adjusted.
In the next instalment of the series we will look at the Test Plan.
For further support and guidance with any aspect of your validation project from full project delivery to individual documentation support please reach out to us at AgosIT.
To see our previous series blog post click here.