FDA CPG 425 series and its 1 linked instrument

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	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.
Lifecycle	19 Oct 1984 Sec. 425.100 originally issued 4 Sep 1987 Sec. 425.100 revised	29 Sep 1978 Published at 43 FR 45077
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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