ChecklistGuro Certificate of Analysis (CoA) Generation Process
Streamline your pharmaceutical quality control with our automated Certificate of Analysis (CoA) Generation Process. Ensure-compliance, eliminate manual errors, and accelerate batch release by digitizing the end-to-end documentation workflow from lab results to final CoA issuance.
Start
Start of the Workflow/Process.
1. Fetch Batch Production Data
Retrieve all raw material test results and production parameters from the Batch Data Model.
2. Fetch Product Specifications
Retrieve the predefined acceptance criteria (min/max limits) for the specific product SKU.
3. Calculate Average Purity
Calculate the average purity percentage from all sampled test entries in the batch.
4. Check Specification Compliance
Compare the aggregated test results against the product specification limits to determine pass/fail status.
5. Update Batch Quality Status
Update the 'Quality Status' field in the Batch Data Model to 'Review Pending' or 'Passed/Failed'.
6. Quality Control Review Task
Create a task for the QC Manager to review the calculated results and verify laboratory findings.
7. Create CoA Draft
Generate a new entry in the Certificate of Analysis Data Model populated with the processed data.
8. Populate CoA Details
Write the specific test values, dates, and technician names into the newly created CoA entry.
9. Final Approval Task
Create a task for the Quality Assurance Lead to digitally sign and approve the CoA.
10. Generate PDF Certificate
Generate the formal, printable PDF document representing the Certificate of Analysis based on the CoA entry data.
11. Finalize CoA Status
Update the CoA entry status to 'Released' or 'Archived'.
12. Notify Production Team
Send an email to the Production Manager with the link to the completed CoA.
13. Notify Client (If Failed)
Send an automated email to the client contact if the specification compliance calculation resulted in a 'Fail'.
End
End of the Workflow/Process.
Start of the Workflow/Process.
Retrieve all raw material test results and production parameters from the Batch Data Model.
Retrieve the predefined acceptance criteria (min/max limits) for the specific product SKU.
Calculate the average purity percentage from all sampled test entries in the batch.
Compare the aggregated test results against the product specification limits to determine pass/fail status.
Update the 'Quality Status' field in the Batch Data Model to 'Review Pending' or 'Passed/Failed'.
Create a task for the QC Manager to review the calculated results and verify laboratory findings.
Generate a new entry in the Certificate of Analysis Data Model populated with the processed data.
Write the specific test values, dates, and technician names into the newly created CoA entry.
Create a task for the Quality Assurance Lead to digitally sign and approve the CoA.
Generate the formal, printable PDF document representing the Certificate of Analysis based on the CoA entry data.
Update the CoA entry status to 'Released' or 'Archived'.
Send an email to the Production Manager with the link to the completed CoA.
Send an automated email to the client contact if the specification compliance calculation resulted in a 'Fail'.
End of the Workflow/Process.
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