spreadsheet validation and requirement [Regulatives / Guidelines]
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
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
Complete thread:
- spreadsheet validation and requirement tarak_desai 2017-04-06 09:46 [Regulatives / Guidelines]
- spreadsheet validation and requirement ElMaestro 2017-04-06 18:47
- spreadsheet validation and requirement Helmut 2017-04-09 21:32
- spreadsheet validation and requirementvish14184 2017-04-16 20:56