Evidence Product Checklist for the FDA Document: “FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule”
Evidence Product Checklist for the FDA Document "FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule" -ISBN 0-9716087-0-9
Format: PDF (Click here for our easy-to-modify Word® formatted version) Language: English Provider: SEPT Shipping: Available for download - Link will be provided in My ComplianceOnline section
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Product Detail:
Checklist for the FDA Document : "FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures; Final Rule".
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.
The Checklist uses a classification scheme of physical evidence comprised of
Procedure
Plan
Records
Document
Review
Audit
When a company is planning to use this document to ensure their compliance to FDA 21
CFR Part 11, the company should review this evidence checklist.
