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GAMP 5 life cycle · Area 03 of five

Verification and validation

Risk-based verification proportional to GAMP category and risk.

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This area
03
Verification and validation
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

This is where specification meets evidence. Verification follows the GAMP 5 V-model – every requirement specified, built and tested – with the depth of testing set by software category and risk rather than applied uniformly.

01
Traceability matrix (RTM)The thread that links each user requirement through functional and design specification to the qualification test that confirms it. Traceability is the first line an inspector follows; a complete matrix shows that every requirement is specified, built and verified, with nothing orphaned.

What we produce. A requirements traceability matrix spanning the URS, functional and design specifications and the IQ / OQ / PQ tests.
Regulatory anchor. GAMP 5 V-model
02
Testing protocols (xQ)Pre-approved installation, operational and performance qualification protocols – test steps, expected results and acceptance criteria. Documented, pre-approved testing is the evidence of fitness for purpose; ad-hoc testing carries no weight at inspection.

What we produce. An IQ / OQ / PQ protocol suite with execution records and defined acceptance criteria.
Regulatory anchor. EU GMP Annex 15 · 21 CFR Part 11
03
Verification summary reportsThe report that consolidates results, resolves deviations and declares the validated state. It is the formal statement the business and the regulator rely on to release the system into GxP use.

What we produce. A validation summary report with documented deviation resolution and a validated-state declaration.
Regulatory anchor. EU GMP Annex 15 · GAMP 5
The five areas

Continue through the life cycle

← Risk assessment and impact analysis   All five areas   Operational control and monitoring →

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.

Start with a short discovery call and we will tell you honestly where we can add value.

Book a Discovery Call The GAMP 5 framework
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Credentials
ISO 9001:2015 certified · IAM Member 1035342
MHRA · FDA · EMA · ICH · BRCGS · GAMP 5
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QMS Gap Assessment · CSV · Method Development