System Validation and Change Control
What you must know
Validation demonstrates that a system consistently produces accurate results. The classic V-model links user requirements to design, build, and testing. Understand IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification). Change control ensures modifications are assessed, approved, tested, and documented before release.
Concepts to master
Know the validation plan, traceability matrix, and risk-based testing. Understand that vendor validation does not replace sponsor validation; the sponsor must verify the system meets its intended use. Recognize that emergency changes require retrospective documentation. Know that change control covers configuration, not just code.
Traps
Questions often imply that a vendor's validation package is sufficient for the sponsor. Watch for changes released without impact assessment. Another trap: confusing IQ with OQ, or treating a minor configuration change as exempt from change control.
Rule of thumb
No change without a record: assess impact, approve, test, release, and document. If you cannot trace a requirement to a test, the validation is incomplete.