FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA Compliance Policy Guides Sec. 425.100 to 425.500: Computerized Drug Processing
Final CSV · Guidance Last verified: not yet · Source last checked 3 Nov 2026
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Early FDA policy guides on computers in drug manufacturing. They explain how the drug GMP rules apply to hardware and software.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Sec. 425.100 originally issued
- Sec. 425.100 revised
In plain English
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.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
These FDA Compliance Policy Guides date from the 1980s, and Sec. 425.100 was first issued on 19 October 1984 and revised on 4 September 1987. They are among the earliest FDA statements on computers in drug manufacturing, and their logic still shapes CGMP thinking.
Who and what it applies to
Drug manufacturers using computers in CGMP functions.
What it contains
- Sec. 425.100
- Hardware is generally treated as equipment, and applications software as records.
- Sec. 425.200
- Vendor responsibility.
- Sec. 425.300
- Source code for process control application programs.
- Sec. 425.400
- Input and output checking.
- Sec. 425.500
- Identification of persons on batch records.
Key points
- How a system is used decides which CGMP sections apply.
- Their age shows how long these principles have stood.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Useful background when explaining why software is treated as a record.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 4 Sep 1987 | Sec. 425.100 revised | Final | Source for Sec. 425.100 revised |
| 19 Oct 1984 | Sec. 425.100 originally issued | Final | Source for Sec. 425.100 originally issued |
Related
How other documents connect to this one. Links explained
- Interprets 21 CFR Part 211· Compare with 21 CFR Part 211 Unverified link
Official source
The official text always prevails over anything on this site.
Source: FDA. Public domain.
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