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Back to the forum  2018-06-18 13:48 CEST (UTC+2h)

spreadsheet validation and requirement [Regulatives / Guidelines]

posted by tarak_desai - India, 2017-04-06 09:46  - Posting: # 17230
Views: 1,661

Hello to all,

Can anyone share regulatory guidance on spreadsheet validation?

I have few questions and need guidance on it.

who should do spreadsheet validation? user department or QA ?

what should be role of user department and QA in spreadsheet validation in GCP environment?

what all validation document required?

Do we need to validate dose calculation sheet for clinical study?


Thanks in advance

Tarak

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