Computer Validation (CSV), must include the under listed tests / inspections, but is not limited to them alone. The inclusion of the 21 CFR Part 11, Applicability is deliberate. This allows the executor of the computer validation (CSV) protocols to clear this requirement by cross referencing the risk assessment reference number and stating Yes or No, to the applicability question. The regulator now does not have to search further, he can see that requirements for 21 CFR Part 11 have been considered and judged.
  • Introduction.
  • Scope.
  • Software Verification.
  • Hardware Verification.
  • Testing Personnel CV & Details Sheet.
  • 21 21 CFR Applicability.
  • Backup Software Storage Security.
  • Menu Navigation.
  • Operating Environment.
  • System Security (physical/access to data).
  • Power Failure Recovery.
  • Test Alarms.
  • System Stress Testing / Boundary Test.
  • Interface Signals.
  • Menu Navigation.
  • 21 21 CFR Part 11 Conformance.
  • Functionality tests.
There is a degree of flexibility in deciding precisely at what stage in the validation process some of these test and inspections are executed. Where this flexibility exists the choice between the IQ or OQ or PQ, must be rationalized and documented in the validation master plan (VMP) or the validation plan (VP).

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