Periodic Review (Validation)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A scheduled reassessment of a qualified system, validated process, or facility to confirm it remains in a validated state, evaluating trend data — deviations, CAPA, change history, calibration and maintenance records — accumulated since the last review, and determining whether requalification or revalidation is warranted.
Periodic review is a discrete, documented look-back exercise, distinct from the continuous monitoring performed under ongoing process verification. On a defined interval — commonly annual for critical systems — the review pulls together everything that has happened to the system since the last review: how many changes went through change control, what deviations and CAPAs touched it, and whether calibration or preventive-maintenance records show any drift.
The output is a documented conclusion, not just a status check: either the system remains validated as-is, or the review identifies a gap that triggers requalification, revalidation, or an update to the validation documentation itself. Because it synthesizes evidence from several other quality systems, a well-run periodic review is often where a site first notices a slow-building problem that no single deviation would have surfaced on its own.
- —A scheduled, discrete review — not the same as continuous ongoing monitoring
- —Evaluates change history, deviations, CAPA, and calibration/maintenance records since the last review
- —Frequency and scope are typically risk-based and defined in the VMP or system-specific plan
- —Conclusion documents whether the system remains validated or requires requalification/revalidation
EU GMP Annex 15; EU GMP Annex 11 (periodic evaluation of computerized systems)
Frequently asked questions
What is Periodic Review (Validation)?
A scheduled reassessment of a qualified system, validated process, or facility to confirm it remains in a validated state, evaluating trend data — deviations, CAPA, change history, calibration and maintenance records — accumulated since the last review, and determining whether requalification or revalidation is warranted.
Which regulations cover Periodic Review (Validation)?
EU GMP Annex 15; EU GMP Annex 11 (periodic evaluation of computerized systems)