On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided. It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It: – allows that electronic copies do...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.