Compare FDA quality systems guide and 21 CFR Part 211
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 quality systems guide interprets 21 CFR Part 211 · Source Unverified link
Side by side
| FDA quality systems guide | 21 CFR Part 211 | |
|---|---|---|
| Authority | FDA | FDA |
| Legal weight | Guidance & Q&A | Law & regulation |
| Status | Final | In force |
| Last verified | Not yet | Not yet |
| Summary | FDA guidance to help manufacturers use modern quality systems and risk management to meet the CGMP regulations in 21 CFR parts 210 and 211. | US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data. |
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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.