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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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