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Registerspreadsheet validation and requirement [Regulatives / Guidelines]
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
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
Complete thread:
- spreadsheet validation and requirementtarak_desai 2017-04-06 09:46 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- spreadsheet validation and requirement ElMaestro 2017-04-06 18:47
- spreadsheet validation and requirement Helmut 2017-04-09 21:32
- spreadsheet validation and requirement vish14184 2017-04-16 20:56
Ing. Helmut Schütz