Field-ready IQ/OQ: what to include and what to avoid
Updated Feb 2026 • Validation / GxP
Include
- Clear scope and boundaries
- Traceability to URS/FS
- Objective evidence: screenshots, logs, timestamps
- Deviations with impact and disposition
- Approvals and version control
Avoid
- Unverifiable statements without proof
- Too many subjective checks
- Missing acceptance criteria
- Copying vendor language without mapping to your environment
Goal: a reviewer should be able to replay the test and get the same result.