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spreadsheet validation and requirement [Regulatives / Guidelines]

posted by vish14184 - India, 2017-04-16 20:56  - Posting: # 17242
Views: 172

Dear tarak,


refer below link of guidance for spreadsheet validation.

https://www.fda.gov/scienceresearch/fieldscience/laboratorymanual/ucm174286.htm#4_5_2

first prepare validation protocol or SOP and define responsibility of validation team (IT, user department and QA), validation strategy depending on risk assessment and it's security. According to SOP/protocol execute validation activities.



With Regards
Vishal Nakrani

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