21 CFR Part 11 and its 3 linked instruments
How to read this page
- First column: 21 CFR Part 11. 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.
| 21 CFR Part 11 | FDA data integrity Q&A | Part 11 scope guidance | FDA electronic systems Q&A | |
|---|---|---|---|---|
| Authority | FDA | FDA | FDA | FDA |
| Legal weight | Law & regulation | Guidance & Q&A | Guidance & Q&A | Guidance & Q&A |
| Status | In force | Final | Final | Final |
| Last verified | Not yet | Not yet | Not yet | Not yet |
| Summary | The US regulation setting the conditions under which FDA treats electronic records and signatures as equivalent to paper records and handwritten signatures: validation, audit trails, access controls, record protection and signature controls. | FDA's question-and-answer guidance on data integrity in drug manufacturing: ALCOA, audit trail review, access controls, shared logins and when electronic data are CGMP records. | 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. | FDA recommendations for sponsors, clinical investigators, review boards and contract research organisations on using electronic systems, records and signatures in clinical investigations, and when FDA treats them as equivalent to paper records and handwritten signatures. |
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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 Source: FDA. Public domain. |
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.