FDA electronic systems Q&A and its 3 linked instruments
How to read this page
- First column: FDA electronic systems Q&A. 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 electronic systems Q&A | Part 11 scope guidance | 21 CFR Part 11 | FDA BA/BE data integrity | |
|---|---|---|---|---|
| Authority | FDA | FDA | FDA | FDA |
| Legal weight | Guidance & Q&A | Guidance & Q&A | Law & regulation | Guidance & Q&A |
| Status | Final | Final | In force | Draft |
| Last verified | Not yet | Not yet | Not yet | Not yet |
| Summary | 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. | 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. | 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. | Draft FDA guidance for applicants and testing sites on achieving and maintaining data integrity in the clinical and bioanalytical parts of bioavailability and bioequivalence studies. |
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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.