Long shot - any GAM...
 

[Closed] Long shot - any GAMP 5 experts in the house?

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Hi,

I'm auditing in India and have found an issue with the QMS of a supplier in that Quality Assurance do NOT sign off on new software releases.

I'm pretty sure this doesn't agree with GAMP 5 but I've neither got a copy with me, nor access to an electronic copy.

Anyone know (or even better can quote)?


 
Posted : 18/02/2015 2:08 pm