FDA CDER Inspection of Computer Systems

FDA CDER “Guide to Inspection of computer systems used in drug processing” issued February 1, 1983. This is the document that started it all. It is quite dated but as of the end of 1999 has not been updated. Many of the more recent software related guidance documents issued by other FDA divisions have had some degree of participation by CDER and provide information that is also relevant to inspection of drug processing computer systems.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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