The Test Report
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 Test Report is an optional deliverable normally required in larger more complex systems. Details usually included within the test report are compiled within the validation report in smaller, less complex projects.
The Test Report pulls together all testing performed for a particular module or project and reports on the metrics and performance of completed testing.
The metrics reported include the following as standard:
- Number of Tests
- Number of Tests Completed
- Number of Tests Not Completed
- Number of Tests Passed
- Number of Tests Failed
- Number of Test incidents
- Number of Open Test Incidents
- Number of Closed Test Incidents
- Actions to Close out Testing
- Actions to Close out Test Incidents
These metrics are used by key stakeholders to assess the systems suitability against the required use cases to inform them when faced with the “Go or No-Go” decision faced in the Validation Report.
All testing must be reported to provide a picture of how successful a system is at meeting the requirements.
The Test Report must compliment the Test Plan in confirming all areas of testing and actions defined within the Test plan have been completed successfully.
In the next instalment of the series we will look at the Validation Report.
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 firstname.lastname@example.org.