cGMP Software
Current Good Manufacturing Practice — cGMP — is the FDA regulatory framework that governs how drugs, biologics, medical devices, and dietary supplements are manufactured, tested, released, and marketed. cGen is cGMP software that supports the computerised-system layer of that framework: 21 CFR Parts 210/211, 820 QMSR, 111 for supplements, and the Annex 11 equivalent in the EU.
The cGMP regulations for drug manufacturing map to specific cGen workflows — controlled records, master batch records, deviation and CAPA management, periodic review.
Drugs (CDER), biologics (CBER), devices (CDRH), and food/supplements (CFSAN) all share the same underlying computerised-system requirements. cGen supports all four.
Annex 11 in the EU, Schedule M in India, PIC/S PI 011-3 — the international cGMP equivalents share the same substrate; cGen produces evidence packs against each.
cGMP is not a piece of software. It is a regulatory framework. But "cGMP software" as a category refers to platforms that manage the computerised-system controls, controlled records, and evidence trails that cGMP inspections rely on.
That covers a lot of ground: manufacturing execution systems, laboratory information management systems, environmental monitoring, batch review and release, deviation and CAPA management, change control, supplier quality, training, and — the layer this platform focuses on — the validation and controlled-record substrate that underpins all of the above.
How cGen fits
cGen does not replace a full eQMS or MES. It does replace — cleanly — the spreadsheets, Word templates, and half-broken validation modules that most cGMP programs still rely on for the CSV/CSA layer. That layer is inspection-critical, and it is the one most teams cannot produce cleanly under audit-day pressure.
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