Computer System PQ Template (RiskVal)

• 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.

It Provides information on:

• System description
• Responsibilities
• Validation approach
• Equipment/materials needed
• Prerequisites
• Protocol report