Practitioner template
GxP Assessment Template
Record whether and how a computerized-system use supports a regulated process, required record, calculation, control, or decision.
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- System and owner
- Business process
- Intended use
- Regulated record or decision
- Potential GxP impact
- Applicability conclusion
- Information needed
- Approver and date
Completed fictional example
Fictional teaching example: This is not an executed or approved validation record.
- System and owner
- Training Management System; Training Process Owner
- Business process
- Qualification of manufacturing personnel
- Intended use
- Calculate whether an operator has completed effective training required for operation OP-21
- Regulated record or decision
- Training status used to permit controlled work
- Potential GxP impact
- An expired operator could be treated as qualified
- Applicability conclusion
- GxP-relevant use; include qualification logic, status interface, access, and record retention
- Information needed
- Confirm the authoritative curriculum version and interface failure response
- Approver and date
- Fictional example - to be completed through the organization's approved process