Validation should be described as a lifecycle
The most reassuring validation story includes requirements, risk, configuration, qualification, and post-go-live control. Buyers want to know that the validated state can be maintained, not just achieved once.
Qualification phases and what they cover
Installation Qualification (IQ) confirms the system is installed correctly and configured to specification. Operational Qualification (OQ) verifies that workflows behave as intended under normal and boundary conditions. Performance Qualification (PQ) demonstrates that the system performs reliably in the actual operating environment over time.
- IQ — installation and configuration verification
- OQ — workflow and function testing
- PQ — real-environment performance evidence
Maintaining the validated state after go-live
Validation does not end at launch. Changes to the system, user base, or operating procedures must pass through change control with impact assessment. Complere's change control module provides the governance structure needed to sustain validated status over time.
