MEDICAL DEVICE INSPECTION WORKFLOW: SAAS SOLUTION FOR FDA & ISO COMPLIANCE AUDITS

Created by ChecklistGuro (https://checklistguro.com)

[ ] Generate New Inspection Record: Creates the initial record for a specific inspection event.
[ ] Retrieve Device Information: Fetches existing asset/device data (e.g., Serial Number, Model) for the inspection scope.
[ ] Assign Inspection Tasks to Personnel: Assigns specific checklists or actions to relevant team members (e.g., Mechanical, Electrical, Software).
[ ] Update Inspection Findings and Non-Conformances (NCs): Allows inspectors to log observations, severity, and necessary corrective actions.
[ ] Retrieve Historical Inspection Data: Accesses previous inspection results and corrective actions for trend analysis.
[ ] Calculate Risk Score from Observations: Automated calculation to prioritize findings based on severity and potential impact (Risk Matrix).
[ ] Generate Corrective Action Request (CAR): Automatically creates tasks for root cause analysis and preventative measures based on failed inspections.
[ ] Generate Final Audit Report: Compiles all inspection data, checklists, and action items into a standardized, client-ready report format.
[ ] Submit Inspection Results Notification: Sends automated email summary to stakeholders (Management, QA) upon completion.
[ ] Urgent Safety Alert Notification: Sends real-time SMS alerts for critical safety findings or immediate hazards.

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