FDA CDRH Inspection Guide Lists FDA SW Contacts

The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software:

“i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem:
Stewart Crumpler
Office of Compliance Software Expert, HFZ-340
Telephone: (301) 594-4659 ext. 119”

Mr. Crumpler is also listed along with Paul Motise of ORA as contacts for Part 11 Electronic Records;Signatures questions.

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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