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.)
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.