Computer System PQ Template (RiskVal)

Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $99.00
Product Details

  • 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


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