WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.