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.
Testing is the key validation deliverable for providing evidence to reviewers and the authorities that a system has been adequately tested for the purposes outlined within the test plan.
Testing takes the form of 3 different protocols:
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
Protocols should be written and maintained in accordance with the document management or project document management procedures and should fall under the remit of the validation plan.
Test Protocols should include detailed instructions for testers, test managers and review/approvers. Test steps should be unambiguous and easy to follow. If a test script was executed by 3 different strangers, they should all generate the same result and evidence.
Test scripts should be completed following Good Documentation Practices (GDocP).
IQ tests will record the installation progress of the system or equipment being installed. For hardware the IQ records basic information such as location, installer, make, model and serial number to name a few. The IQ serves as proof that what is installed is what is defined within the design and specifications for the equipment or system.
OQ testing provides assurance that a system functions correctly as per the configuration. OQ testing can be leveraged from a supplier for our of the box functionality. Any configured and updated functionality should be tested as part of the OQ testing. OQ testing is usually performed within the UAT environment if available.
PQ testing focuses on the performance of the system under normal operating conditions either in the UAT environment using conditions and sample sets appropriate to test an operational setting, or in the live environment under controlled testing conditions to test the process performance with real users and data.
In the next instalment of the series we will look at the Test 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 email@example.com.