GAMP Software Categories
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
GAMP 5 classifies computerized systems into software categories to scale validation effort to risk and complexity: broadly infrastructure software, non-configured (off-the-shelf used as supplied), configured, and custom/bespoke software. The category, combined with risk, determines how much specification and verification a system needs.
The categories are commonly numbered — infrastructure software (category 1), non-configured products (category 3), configured products (category 4), and custom applications (category 5); an older category 2 (firmware) was retired in favor of treating it under other categories. Higher categories carry greater potential for defects introduced during configuration or coding, so they demand deeper design specification and testing.
The classification is not a checklist that decides validation by itself — it is an input to a risk-based approach. A high-risk configured system may need more rigor than a low-risk custom utility, so category and functional risk are applied together.
- —Categories: infrastructure (1), non-configured (3), configured (4), custom (5).
- —Category 2 (firmware) was retired in GAMP 5.
- —Higher category = more configuration/coding risk = deeper V&V.
- —Applied together with functional risk, not alone.
GAMP 5 Second Edition (2022) software categories (appendix M-series).
Frequently asked questions
What is GAMP Software Categories?
GAMP 5 classifies computerized systems into software categories to scale validation effort to risk and complexity: broadly infrastructure software, non-configured (off-the-shelf used as supplied), configured, and custom/bespoke software. The category, combined with risk, determines how much specification and verification a system needs.
Which regulations cover GAMP Software Categories?
GAMP 5 Second Edition (2022) software categories (appendix M-series).