FDA CSA guidance and its 3 linked instruments
How to read this page
- First column: FDA CSA guidance. The others are every document linked to it.
- Scroll sideways if there are more columns than fit.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
| FDA CSA guidance | FDA software validation | Part 11 scope guidance | ISPE GAMP 5, 2nd ed. | |
|---|---|---|---|---|
| Authority | FDA | FDA | FDA | ISPE |
| Legal weight | Guidance & Q&A | Guidance & Q&A | Guidance & Q&A | Industry good practice |
| Status | Final | Final | Final | Industry guide |
| Last verified | Not yet | Not yet | Not yet | Not yet |
| Summary | FDA's risk-based approach to assuring software used in production and quality systems, favouring critical thinking and unscripted testing where risk is lower. Final since September 2025 and updated in February 2026 to align with the QMSR. | FDA guidance setting out the validation principles it considers applicable to medical device software, and to software used to design, develop or manufacture medical devices. | FDA guidance on how it applies Part 11. FDA says it will not enforce certain requirements on validation, audit trails, record retention and record copying, and sets criteria for legacy systems. Part 11 remains in effect, and predicate rule requirements still apply. | Industry good-practice guide for the lifecycle of GxP computerised systems, widely referenced by regulators and companies. Proprietary: cite and link only. |
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| Source | Official text Source: FDA. Public domain. | Official text Source: FDA. Public domain. | Official text Source: FDA. Public domain. | Official text Summary in our own words. See the official text from ISPE. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.