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GAMP 5 life cycle · Area 05 of five

Supplier and third-party management

Assess and audit suppliers to rely on their life cycle documentation.

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This area
05
Supplier and third-party management
Control points
2
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

Two control points

GAMP 5 lets a regulated organisation draw on a supplier’s own development and testing evidence – but only in proportion to how well that supplier is assessed. This area sets that reliance on a defensible footing, and keeps it there through the support relationship.

01
Supplier assessmentAssessment and, where the risk warrants it, audit of the supplier’s quality system and development life cycle. For configured and non-configured systems, the depth of supplier evidence you can rely on directly reduces your own testing burden – but only where the supplier has been assessed and scored.

What we produce. A supplier GAMP audit checklist with a scored assessment of the supplier’s quality system and maturity.
Regulatory anchor. GAMP 5 · EU GMP Annex 11
02
SLA and supportThe service-level agreements that define support, maintenance, change notification and data responsibilities. The validated state persists only where the supplier’s obligations are defined and enforceable; vague support terms leave compliance gaps that surface at the worst moment.

What we produce. A defined set of service-level agreements covering the GxP-critical support obligations.
Regulatory anchor. EU GMP Annex 11 · GAMP 5
The five areas

Continue through the life cycle

← Operational control and monitoring   All five areas

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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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