Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (RiskVal)

Provider: BPA
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  • This procedure applies to all computer system validation plans, protocols (IQ, OQ, or PQ), protocol reports , and Validation Final Reports.
  • A Validation Plan defines the validation approach, activities, responsibilities, procedures, and requirements for the validation of a system or an item.
  • All test equipment used in the PQ was properly calibrated before use in the test. Copies of calibration certificates are attached to an appendix.
  • If the system acceptance criteria places limits on the number of critical, major, or minor defects that are permissible (e.g., none), the numbers permitted for one OQ protocol can be equal to or fewer than the numbers allowed for the entire system.

It Provides information on:

  • Responsibilities
    • Project Team
    • System Owners are responsible for
    • Quality Assurance (QA) is responsible for
  • Method
    • Life cycle approach
    • Conceptualize
    • Select Vendors and Systems
  • Quality Records

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