MEDICAL DEVICE INSPECTION WORKFLOW: BEST PRACTICES FOR FDA/ISO AUDIT MANAGEMENT

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[ ] Initiate Inspection Checklist: Creates a new, trackable record for the inspection based on a specific device model or site location.
[ ] Retrieve Latest Device History Records: Pull historical inspection data and associated corrective actions for the specific medical device.
[ ] Record New Inspection Finding/Observation: Allows inspectors to log non-conformities, deviations, or observations with timestamps and evidence.
[ ] Assign Follow-up Action Items: Automatically generates and assigns tasks to responsible personnel for necessary corrective actions (CAPA).
[ ] Update Inspection Status (Pass/Fail): Marks the overall status of the inspection record, triggering next steps or approvals.
[ ] Calculate Inspection Completion Score: Aggregates data points (e.g., % items checked, overdue tasks) to generate an overall pass/fail score for reporting.
[ ] Generate Final Inspection Summary Report: Compiles all gathered data, tasks, and findings into a formal, shareable audit report.
[ ] Alert Stakeholders of Critical Non-Conformance: Automatically notifies relevant department leads or management via email immediately upon logging a critical finding.
[ ] Instant Notification for Failed Critical Checkpoints: Sends urgent SMS alerts to site managers when immediate corrective action is required during an inspection.

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