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 Question:
Is there any regulatory guideline for Vendor Qualification? If it is there please refer the URL/WEB address an Question Id:2503
Srk
09-28-2007 10:09PM
User Id: 87527
 
 User Answer
Dana Yurach
10-08-2007 08:10AM
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Dear Member,
One possibility would be to consider the relevant sections of FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Document issued on: January 11, 2002. One note is to carefully review and consider the scope and applicability of this guidance.

http://www.fda.gov/cdrh/comp/guidance/938.html
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