For the standard FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, Final Rule
Download (MSWORD format), 540 KB, 31 Pages, (also available in MS WORD format)
Item No.: RCG013ARCG, published October 2001
Checklist for the FDA document: 21 CFR Part 11 - Electronic Records; Electronic Signatures; Final Rule. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. It identifies over 50 pieces of physical evidence. This checklist clarifies what is required for compliance to this standard by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard FDA 21 CFR Part 11. Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. The purchase of the checklist includes four hours of free consultation during 60 days after date of purchase, concerning questions about the standard and the checklist. The Checklist is a quality product at a reasonable price!