software update [GxP / QC / QA]

posted by Ohlbe – France, 2010-03-08 00:35 (5542 d 21:18 ago) – Posting: # 4873
Views: 4,603

Dear Ramesh,

❝ For example i had carried out the validation in analyst 1.4.1 now i upgrading my software to analyst 1.5.

❝

❝ now what are the requirements or documents to generated in compliance with the regulatory.


The requirement is you have to validate your software...

❝ whether i have to prove the precision and accuracy batch after installing the updated software.


... and not to validate a specific method, or just perform one run and say "OK, it works".

Regards
Ohlbe

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