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FDA
- Medical Software
General Principles
of Software Validation |
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Evidence
Product Checklist for the FDA document
General Principles of Software Validation
Final Guidance for Industry and FDA
Staff
Release date January 11, 2002
by Stan Magee
E-Book
118 Pages
Published March
2002
Download (PDF) 178 KB
Item No.: RCG14SEPTISO
List Price: US $ 149.00 |
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Description
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! |
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