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About This Item


Full Description

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.

New! Order the "Self-Extracting File Format" option to get this template in as an editable Microsoft Word document!

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.

Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements.

The Checklist is a quality product at a reasonable price!

Download a sample of the new checklist (PDF format).

New! Interested in an unlimited 5-year corporate license for this product? Contact Software Engineering Process Technology (SEPT) for more information! Tel. 425-391-2344, Fax 425-557-9419.