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FDA 21 CFR Part 11
electronic records,
electronic signatures, final rule electrical equipment
Checklist |
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Evidence
Product Checklist for FDA Document
“FDA 21 CFR Part 11 Electronic Records;
Electronic Signatures; Final Rule”
by Stan Magee
E-Book
30 Pages
Published October
2001
Download (PDF) 55 KB
Item No.: RCG17SEPTISO
List Price: US $ 149.00 |
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Description
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
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! |
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