This PQ template provides extensive examples and instructions on how to create a Performance Qualification protocol for the validation of a specific computer system.
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Product Detail:
This protocol provides documented evidence that the [system name] performs in a production environment per requirements. This protocol is compliant with the requirements of VAL004.
This protocol tests/verifies the functioning of the change control module of the EDMS System , and the ability to view controlled documents using the EDMS system , per requirements, in an operational environment.
Validation is responsible for protocol generation and for assuring that the requirements are appropriately tested. Validation is also responsible for coordinating the protocol execution activities.
Quality Assurance is responsible for the review and approval of the qualification protocol as it relates to current good manufacturing practices (cGMPs), and other regulatory requirements.
Errors in protocol test instructions may be corrected on the protocol without completing a Variance Report as long as the correction does not impact the nature of the test or the nature of the expected results.
