Situation
Robotic process automation (RPA) reads an approved mailbox attachment and creates a draft Quality event in eQMS.
Intended Use
Transcribe defined fields and attach the source document. A qualified user reviews and submits the draft; the robot cannot approve or close the event.
Decision Summary
| Decision element | Case record |
|---|---|
| GxP assessment | Incorrect transcription, missing source, duplicate creation, unauthorized action, or hidden exception can weaken the controlled Quality record. |
| Potential impact | A Quality event can be incomplete, delayed, duplicated, or associated with the wrong source. |
| Known issue | A fictional timeout creates two drafts because the robot cannot confirm the first transaction. |
| Validation conclusion | Production use is restricted until an idempotency key and accountable exception queue are implemented and retested. |
GxP Assessment
Incorrect transcription, missing source, duplicate creation, unauthorized action, or hidden exception can weaken the controlled Quality record.
Affected GxP Functions
- Source-file selection
- Field extraction and mapping
- Draft record creation
- Attachment and source linkage
- Exception handling and reconciliation
Failure Scenarios
- Wrong attachment is selected
- Date or identifier is misread
- Retry creates a duplicate
- Robot uses excessive privilege
- Failure is logged but not resolved
Potential Impact
A Quality event can be incomplete, delayed, duplicated, or associated with the wrong source.
Existing Controls
- Approved mailbox
- Read-only source
- Dedicated service account
- Human draft review
- Daily transaction reconciliation
Existing Evidence
- Qualified RPA platform
- Approved mapping specification
- Prior eQMS validation
- Controlled deployment pipeline
Evidence Gaps
- Poor-quality attachment handling
- Timeout and retry
- Credential rotation
- eQMS screen change
Testing Approach
- Script exact field, format, attachment, and role behavior
- Challenge unreadable, duplicate, missing, and malformed sources
- Test timeout, retry, partial creation, and safe stop
- Verify draft review, source link, audit history, and reconciliation
Deviations or Known Issues
A fictional timeout creates two drafts because the robot cannot confirm the first transaction.
Validation Conclusion
Production use is restricted until an idempotency key and accountable exception queue are implemented and retested.
Reassessment Criteria
- Source format change
- RPA or eQMS interface change
- Credential or permission change
- Process or mapping change
- Duplicate or missed-event incident