Validation vs UAT

Tagged: Databases, EDC, UAT, Validation

This topic has 2 replies, 2 voices, and was last updated 12 months ago by Kai Antionette.

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- April 12, 2023 at 10:13 pm #5004
  Kai Antionette
  Participant
  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 ago by Kai Antionette.
- April 13, 2023 at 6:39 am #5006
  
  Eldin Rammell
  Participant
  
  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.
  - April 27, 2023 at 8:22 pm #5011
    
    Kai Antionette
    Participant
    
    Thank you, Eldin. I have had many discussions about this, so your input is appreciated.
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