Regulatory Labeling and Packaging Control

Ensure-compliance and precision with our streamlined Regulatory Labeling and Packaging Control workflow. Designed specifically for the pharmaceutical industry, this process optimizes lifecycle management, mitigates mislabeling risks, and guarantees adherence to global health authority standards (FDA, EMA, etc.) from artwork creation to final packaging verification. Stay audit-ready and protect patient safety with automated regulatory oversight.

Старт
1. Fetch Product Specifications
2. Retrieve Regulatory Requirements
3. Calculate Expiry Date Buffer
4. Draft Artwork Label
5. Create Label Version Entry
6. Regulatory Compliance Review
7. Update Review Status
8. Summarize Ingredient Allergens
9. Packaging Material Verification
10. Fetch Supplier Certifications
11. Verify Barcode Checksum
12. Final Artwork Approval
13. Notify Stakeholders of Approval
14. Mark Label as 'Released'
15. Generate Compliance Audit Trail
Край

Начало на работния поток/процеса.

Retrieve all technical specifications and ingredient lists from the Product Master Data Model.

Fetch applicable regional regulatory constraints based on the target market (e.g., EU, FDA, China).

Calculate the stability-tested shelf life minus a safety margin to determine the printed expiration date.

Assign a task to the Graphic Designer to create the initial label artwork based on product specs.

Generate a new entry in the Label Version Control data model for the new artwork iteration.

Assign a task to the Regulatory Affairs Specialist to verify the artwork against regional requirements.

Update the 'Review Status' field in the Label Version entry to 'Approved' or 'Rejected'.

Aggregate all allergen-related ingredients from the product entry to create a consolidated allergen summary.

Assign a task to the Packaging Engineer to ensure the physical material (e.g., foil, plastic) is compatible with the print.

Retrieve certificates of analysis/compliance from the Supplier Data Model for the packaging materials.

Execute a formula to validate that the generated GTIN/EAN barcode string is mathematically valid.

Assign a task to the Quality Assurance Manager for final sign-off on the complete package design.

Send an email to the Production and Supply Chain teams notifying them that the label is approved for print.

Update the status of the specific Label Version entry to 'Released for Production'.

Create a report summarizing all changes, approvals, and regulatory checks performed during this process iteration.

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