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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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