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.
The Test Plan (also known as the Test Strategy) defines the approach that will be taken to test a GxP system. The Test Plan takes into consideration the following:
- Risk assessment
- GAMP Category of the system
- Complexity and novelty of the system
- Results of the supplier audit (if applicable)
The Test Plan is used to define the following key information:
- Types of testing to be performed
- The number of tests and test specifications
- The purpose of the tests
- The use of supplier provided documentation/specifications
- The planning of each test phase (Resources, Responsibility and Location)
- How evidence will be captured (screenshots, witnesses, reports, etc.)
- How test failures will be managed
- The format and structure of test documentation
- What metrics will be tracked throughout testing
The Test Plan is a key document in ensuring a successful testing phase for your validation projects. The Test Plan pulls together all of the key information required for a tester and test manager to compliantly test, capture evidence and document the GxP testing process.
In the next instalment of the series we will look at Test Specifications.
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 protected].
To see our previous series blog post, please click here