For the FDA document General Principles of Software Validation - Final Guidance for Industry and FDA Staff
Download (PDF) 178 KB, 118 pages (also available in MS WORD format)
Item No.: RCG010ASEP, published March 2002
Evidence product checklist for the FDA document “General Principles of Software Validation” - Final Guidance for Industry and FDA staff. The checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard. 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. Use of the checklist will save time and money, and may aid in meeting certain governmental requirements. A quality product at a reasonable price!