Saturday, 23 May 2015
"Agile" Over view [PPT]
Click here for "Agile" Over view [PPT]
Saturday, 16 May 2015
PRINCIPLES OF SOFTWARE VALIDATION BY USFDA
Click here for "General Principles of Software Validation; Final Guidance for Industry and FDA Staff"
ISPE Risk based approach to 21 CFR PART 11
Click here to view ISPE_Risk based approach to 21CFRPart
11
Wednesday, 13 May 2015
21CFR Part 11 sample check list
Click here for 21CFR Part 11
sample check list
Sunday, 10 May 2015
Difference between 21 CFR Part 11 and EU Annex 11
Click here for Difference between 21 CFR Part 11 and EU Annex 11
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