Compare FDA electronic systems Q&A and Part 11 scope guidance
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- FDA electronic systems Q&A complements Part 11 scope guidance · Source Unverified link
Side by side
| FDA electronic systems Q&A | Part 11 scope guidance | |
|---|---|---|
| Authority | FDA | FDA |
| Legal weight | Guidance & Q&A | Guidance & Q&A |
| Status | Final | Final |
| Last verified | 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. |
| Lifecycle |
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| Source | 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.