What do you include in your OQ

Operational Qualification should cover the following but is not limited to:

  • Input/output testing
  • Alarm and message handling
  • Reporting
  • Security
  • Audit Trail for Electronic Records
  • Fail Safe Modes
  • Power Failure Recovery
  • Demonstration of standard functionality of commercial off the shelf (COTS) applications/packages
  • Electronic Record and Signature Functions
  • Application Software, sequential operation
  • Critical Algorithm Testing
  • Interface Communications to related systems
  • Confirmation of system backup / restore and archiving / retrieval functions

We’ve always taken the tack that OQ verifies requirements.

I personally wouldn’t mix in part 11 compliance with OQ.

We have a separate section in the OQ which deals specifically with
21 CFR Part 11 stuff such the usual,

  • Electronic Signatures
  • Electronic Records
  • Audit Trails