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GAMP 5 life cycle · Area 01 of five

Quality and compliance management

Establish the foundation – policies, procedures and roles.

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This area
01
Quality and compliance management
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

Every defensible validation programme rests on a foundation that exists before any single system is tested – a known inventory, a written strategy and a quality system that keeps both current. This area establishes that foundation and the governance around it.

01
System inventoryA complete register of the computerised systems in the facility, each classified by its GxP impact and its GAMP software category. You cannot validate – or defend at inspection – an estate you have not catalogued; the inventory sets the scope, the priority and the proportionate effort for everything that follows.

What we produce. A GxP system inventory with a per-system impact determination and GAMP category, maintained as a living register.
Regulatory anchor. GAMP 5 · EU GMP Annex 11
02
Validation Master Plan (VMP)The site-level strategy that defines validation policy, scope, responsibilities, documentation standards and change control. The VMP is the backbone of a programme an inspector can follow; without it, validation is inconsistent between systems and fragile under scrutiny.

What we produce. A Validation Master Plan aligned to EU GMP Annex 15 and GAMP 5, written as a living governance document rather than a static artefact.
Regulatory anchor. EU GMP Annex 15 · GAMP 5
03
QMS integrationThe procedures, roles and training that embed validation into the quality management system. Validation that sits outside the quality system decays; integration keeps procedures, competence and records current and audit-ready between projects.

What we produce. Validation SOPs and a role-based training matrix integrated with the quality management system.
Regulatory anchor. ICH Q10 · EU GMP Chapter 4
The five areas

Continue through the life cycle

All five areas   Risk assessment and impact analysis →

Next Steps

Validating this class of system
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Credentials
ISO 9001:2015 certified · IAM Member 1035342
MHRA · FDA · EMA · ICH · BRCGS · GAMP 5
Related Services
QMS Gap Assessment · CSV · Method Development