Registered on 04-13-06
02-04-09 02:30 AM - Post#5510
In response to PaulS
While it is true that GAMP is a document recognized by the FDA, it is seen by the FDA as an adjunct to their Part 11 rules...
"For further guidance on validation of computerized systems, see FDA's guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide".
If a firm were to use GAMP alone as the basis of electronic records / signatures, it would need to have a documented risk assessment / gap analysis, to ensure that any areas not covered by GAMP are acknowledged and rationalized.