GAMP 5 Compliance Software
GAMP 5 is the ISPE's risk-based framework for validating computerized systems in life sciences. The 2nd edition (2022) explicitly blesses cloud/SaaS validation, critical thinking, and supplier leverage. cGen is GAMP 5 software built from that framework, not retrofitted to it.
The GAMP 5 category drives the default test approach automatically — Cat 1 infrastructure, Cat 3 non-configured products, Cat 4 configured, Cat 5 bespoke — each with its own evidence template.
Second-edition GAMP 5 explicitly recognises multi-tenant SaaS. cGen supplies the supplier assessment, cloud-service-provider controls, and shared-responsibility matrix that inspectors expect.
The "critical thinking" the 2nd edition asks for is a documented rationale — cGen captures it inline against each system, so it becomes part of the record rather than a slide deck.
GAMP 5 is not an FDA regulation. It is an ISPE good-practice guide that has become the de facto standard for structuring GxP computer-system validation projects. Inspectors expect you to reference it; auditors expect to see its categories and vocabulary in your protocols.
The 2nd edition, published in 2022, made three shifts that matter for the software you validate on: it embraced cloud and SaaS as first-class deployment models, it asked for evidence of critical thinking (not just checkbox testing), and it acknowledged that AI-assisted authoring is a legitimate part of a modern validation approach — subject to the usual human-in-the-loop controls.
How cGen fits
The cGen team includes practitioners who have led validation programs against GAMP 5 for two decades. The workflow reflects the ISPE recommendations directly — not a marketing overlay on a generic document management system.
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