GxP Resource Hub · Tool
GAMP 5 Category Risk Calculator
Answer three questions about a computerized system to estimate its GAMP 5 (2nd edition, 2022) software category and the principal validation controls that follow.
GAMP 5 v2
Risk-based
~60 seconds
No data leaves the page
Risk-based
~60 seconds
No data leaves the page
Question
Help text
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Recommended GAMP 5 Category
Category
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Principal Validation Controls
Heuristic only. This tool offers a starting point for risk-based categorization
under ISPE GAMP 5 (2nd edition, 2022). Final categorization is a documented QA
decision and must reflect patient/product/data impact, supplier assessment, intended
use, and regulatory context.
under ISPE GAMP 5 (2nd edition, 2022). Final categorization is a documented QA
decision and must reflect patient/product/data impact, supplier assessment, intended
use, and regulatory context.