Validation vs UAT

[Kai Antionette]

What are sponsors filing in section 10.04.03 (Validation Documentation)?

Are you filing system/software validation documentation (i.e IT/QA testing of system requirements, compliance, and functionality) or end-user documentation of the study-specific database built on system/software (e.g. site user, DM, etc.)

• This topic was modified 1 year, 5 months ago by Kai Antionette.

[Eldin Rammell]

Hi Kai

The intention was for this artifact to hold evidence of the study-soecific validation activities. So it would not hold validation documents for the whole system (eg validation of the ePRO software itself) but rather validation of study-soecific configuration.

Kind regards
Eldin.

[Kai Antionette]

Thank you, Eldin. I have had many discussions about this, so your input is appreciated.

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