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FDA 21 CFR 11 CHECKLIST

2012 Edition, January 10, 2012

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Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: “FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule”



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Product Details:

  • Revision: 2012 Edition, January 10, 2012
  • Published Date: January 10, 2012
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Software Engineering Process Technology (SEPT)
  • Page Count: 31
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

Checklist for the FDA Document: "FDA 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