COMPLIANCE

Built to support global traceability requirements

ChekTrace is designed around GS1-aligned traceability principles and supports compliance needs across multiple markets — without turning your operations into a standards documentation exercise.

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GS1 STANDARDS

GS1-aligned traceability

✓ DSCSA, FMD, and national regulatory alignment
✓ Lot-level serialisation manufacturer to dispenser
✓ Temperature excursion flagging via scan metadata
✓ Recall management with full downstream traceability
✓ Automated regulatory reporting and audit trails
REGULATORY FRAMEWORKS

Multi-market regulatory support

✓ Multi-tier distribution visibility from factory to shelf
✓ Grey-market diversion detection & corridor alerts
✓ Consumer-facing verification via product QR scan
✓ Pricing protection via movement monitoring
✓ Batch-level recall management
What's auto-generated
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Full chain-of-custody records

Every handoff logged with operator, location, timestap, and approval status

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GS1-formatted export

Report export in GS1-complaint format for direct regulatory submission

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Alert resolution audit trail

Every alert, actiontaken, and resolution logged for regulatory review

Security & infrastructure

Built on Microsoft Azure with private networking, role-based access control, AES-256 encryption at rest and in transit, and full GDPR-compliant data residency

Role-based access

Configurable permissions by role, region, and product category. Compliance officers, brand protection teams, and operations managers each see only what they need.

Audit trail

Every action, every scan, every alert, and every system change is immutably logged with user, timestamp, and context. Fully exportable for regulatory review.

FAQ

Compliance questions answered

Is ChekTrace certified to GS1 standards?

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ChekTrace is designed around and aligned with GS1 traceability principles. Our data structures support GTIN, SSCC, GLN, and EPCIS event formats. We work closely with GS1 national organisations in key deployment markets.

Can we use ChekTrace for DSCSA compliance in the US?

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Yes. ChekTrace supports key DSCSA requirements, including serialization, product traceability, verification, and electronic record-keeping. It can be configured to support GS1 EPCIS-based data exchange, helping pharmaceutical companies meet U.S. drug supply chain compliance requirements while improving supply chain visibility.

Where is our data stored?

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Chekkit securely stores data in cloud infrastructure with enterprise-grade security, encryption, and access controls. Data residency options can be configured based on customer requirements and applicable regulatory obligations.

Can we export compliance reports for regulators?

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Yes. ChekTrace provides configurable reports and dashboards that can be exported in standard formats for regulatory submissions, audits, inspections, and compliance reporting.

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Traceability and anti-counterfeit infrastructure for regulated and high-trust market worldwide

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