Compare FDA CPG 425 series 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 CPG 425 series interprets 21 CFR Part 211 · Source Unverified link
Side by side
| FDA CPG 425 series | 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 compliance policy on computers in drug manufacturing. Under CGMP, hardware is generally treated as equipment and applications software as records, and the system's use decides which sections apply. The series also covers vendor responsibility, source code for process control, input and output checking, and identifying persons on batch records. | 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.