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.
A validation report is a comprehensive document outlining the validation package and its deliverables in relation to the validation plan. The report details all the documents, records and evidence within the validation package including any issues and risks discovered during the validation process.
The validation report mirrors the sections within the validation plan to describe how each deliverable was created and to what extent.
The validation report serves to act as the formal sign off on a system validation project. Key stake holders should assess the report carefully taking into account any issues, documents or testing to ensure the system is fully validated and fit to be released into production.
Upon signing off of the validation report the system is considered validated.
In the next instalment of the series we will look at the supporting validation documents such as the System Access 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 at email@example.com.