GxP Resource Hub · Tool
GAMP 5 Category Risk Calculator
Answer three questions to get a preliminary, component-level estimate of the GAMP 5 (2nd edition, 2022) software category and the verification activities to consider. This is a screening aid, not a formal validation assessment. GxP impact, complexity, and novelty scale the verification; they do not change the category.
GAMP 5 v2
Risk-based
~60 seconds
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Question
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Indicative GAMP 5 Category (per component)
Category
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Verification Considerations (not prescribed tests)
Worked examples
- Commercial product used as supplied, only environment settings entered: indicative Category 3. High GxP impact deepens verification but does not make it Category 4 or 5.
- LIMS or MES with workflows configured through the supplier’s standard tools: indicative Category 4. Functional configuration is not custom code.
- Configured MES plus a custom calculation script: the configured product is assessed as Category 4 and the custom script separately as Category 5 — one system, several categories.
Screening aid only. This calculator gives a preliminary, component-level estimate
under ISPE GAMP 5 (2nd edition, 2022), not a definitive classification or a validation
plan. The regulated organization documents and approves the assessment based on how each
component is actually supplied, configured, or developed for its intended use. GxP impact,
complexity, novelty, and the supplier assessment then determine the extent of verification.
A computerized system often contains components from more than one category, and
categorization is not a checklist for validation.