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GAMP 5 life cycle · Area 04 of five

Operational control and monitoring

Maintain the validated state through operational control and ongoing monitoring.

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This area
04
Operational control and monitoring
Control points
3
in this area, each producing a named output
Part of
GAMP 5
the risk-based system life cycle
MHRA · FDA · EMA · ICH
GMP · GDP · GLP · ISO 9001
GAMP 5 · 21 CFR Part 11 · Annex 11
BRCGS · HACCP · ALCOA+
Biologics & Advanced Therapies · Food Safety
In this area

Three control points

Validation is not a one-time event. The validated state persists only where access is controlled, deviations are managed and the system is reviewed as it changes, upgrades and ages – the phase where most inspection findings actually arise.

01
Access and security controlDefined user roles, permissions and segregation of duties, evidenced in an access matrix. Data integrity and the electronic-records requirements of 21 CFR Part 11 and Annex 11 depend on controlling who can do what; uncontrolled access undermines every record the system holds.

What we produce. A system access matrix with role-based permissions and a periodic access review.
Regulatory anchor. 21 CFR Part 11 · EU Annex 11 · ALCOA+
02
Incident and deviation managementThe process that records, classifies, investigates and closes deviations affecting the system. Deviations are inevitable; how they are managed is what inspection judges, and untracked deviations become findings.

What we produce. A deviation and CAPA workflow with classification, root-cause analysis and trend tracking.
Regulatory anchor. ICH Q10 · EU GMP Chapter 1
03
Ongoing periodic reviewA scheduled review that confirms the system remains in its validated state through change, upgrade and daily use. Validated state decays with every change; periodic review is how continued compliance is demonstrated between projects.

What we produce. A periodic review protocol and schedule with documented outcomes and actions.
Regulatory anchor. EU GMP Annex 11 · GAMP 5
The five areas

Continue through the life cycle

← Verification and validation   All five areas   Supplier and third-party management →

Next Steps

Validating this class of system
or recovering one that was not?

We scope to your regulatory context, product portfolio and operating reality: prospective or retrospective, a single system or a site-wide programme.

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Credentials
ISO 9001:2015 certified · IAM Member 1035342
MHRA · FDA · EMA · ICH · BRCGS · GAMP 5
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