GOOD MANUFACTURING PRACTICE (GMP) COMPLIANCE WORKFLOW

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[ ] Initiate Deviation Report: Create a new entry in the Deviation Data Model to document a non-compliance event.
[ ] Log Investigation Start: Update the Deviation entry with the current timestamp and 'In Investigation' status.
[ ] Fetch Relevant SOPs: Retrieve all Standard Operating Procedures (SOPs) related to the specific manufacturing area involved in the deviation.
[ ] Assign Root Cause Analysis (RCA): Create a task for the Quality Assurance specialist to perform the RCA using the 5-Whys or Fishbone method.
[ ] Calculate Impact Score: Calculate a risk score based on product criticality, batch volume, and regulatory impact variables.
[ ] Retrieve Batch Records: Fetch all batch entries associated with the affected production lot.
[ ] Aggregate Total Affected Units: Sum the quantity field from all retrieved batch entries to determine the total volume of potentially impacted product.
[ ] Assign CAPA Assignment: Create a task for the Production Manager to define Corrective and Preventive Actions (CAPA).
[ ] Generate CAPA Entry: Create a new entry in the CAPA Data Model linked to the original Deviation entry.
[ ] Update Deviation Status to 'Closed': Update the original Deviation entry status to 'Closed' once all investigations are complete.
[ ] Notify Quality Head: Send an email notification to the Head of Quality containing the summary of the closed deviation.
[ ] Generate Monthly Compliance Summary: Generate a periodic report summarizing all deviations and CAPAs closed during the current month.
[ ] Remove Draft/Invalid Entries: Delete any duplicate or incorrectly filed deviation drafts that do not meet minimum data requirements.
[ ] Urgent Alert Notification: Send an SMS to the On-call Supervisor if the deviation is flagged as 'Critical' during the calculation phase.

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