Regulatory Traceability
What Is Regulatory Traceability?
Regulatory Traceability refers to the mandatory ability to track and document a product’s movement, transformation, and custody across the supply chain as required by government regulations or industry standards.
Unlike voluntary traceability programs, regulatory traceability is enforced by laws, compliance frameworks, and safety mandates — especially in pharmaceuticals, agro-chemicals, food, cosmetics, and medical devices.
It ensures that products can be traced from origin to consumption, with verified, tamper-proof records for audits, recalls, inspections, and safety verification.
Why Regulatory Traceability Exists
Governments and regulators enforce traceability to:
- Prevent counterfeit and substandard products
- Protect consumer health and safety
- Enable fast and precise recalls
- Ensure manufacturing and distribution compliance
- Strengthen transparency across global supply chains
- Detect diversion, adulteration, or contamination issues
Regulatory traceability is critical wherever public safety or high-value goods are involved
Industries Where Regulatory Traceability Is Mandatory
- Pharmaceuticals (DSCSA, EU FMD, India DAVA)
- Agro-chemicals & fertilizers
- Food & beverages (FDA FSMA, FSSAI)
- Cosmetics & personal care
- Medical devices
- Tobacco (T&T frameworks)
Automotive & electronics components (compliance-driven)
Core Elements of Regulatory Traceability
1. Unique Identifier Compliance
Serialized codes, secure QR, GS1 standards, or non-cloneable IDs.
2. Event Recording
Who handled the product, when, and where.
3. Data Storage & Audit-Ready Logs
Tamper-proof event history for regulators.
4. Reporting to Government Portals
Submission of traceability data to mandated systems.
5. Recall & Risk Management Compliance
Quickly isolating defective or dangerous lots.
6. Interoperability
Integration with ERP, WMS, LIMS, and national traceability platforms.
How Regulatory Traceability Works
- Manufacturer assigns compliant product identifiers.
- Each supply chain event (packaging, shipping, receiving) is recorded.
- The Digital Twin stores compliance-ready data.
- Data is shared—often in standardized formats—with regulators.
- Recall or inspection workflows use the traceability dataset.
Example: Agro-Chemical Regulatory Traceability
- Batch is assigned a GS1 or regulatory-compliant code
- Distributor movements are logged
- Retailer sales are captured
- Farmer verification is recorded
- Recall or audit queries pull batch-level histories instantly
This ensures safety, authenticity, and compliance.
How Acviss Supports Regulatory Traceability
Acviss provides:
- GS1 and regulatory-compliant code generation
- Unit- and batch-level traceability
- Secure QR or non-cloneable identifiers
- Digital Twin with compliance event logs
- API submission to government portals
- Recall automation tools
- Audit-ready dashboards
Brands meet compliance requirements while strengthening supply chain integrity.
Related Articles
Boosting Supply Chain Transparency and Traceability Through Inline Printing
A New Age of Product Authentication with AI Labels
