Regulatory Alignment

TrusCodes is designed to support regulation-aligned serialization and verification in audit-sensitive environments. This section explains how our controls and evidence outputs map to common regulatory expectations—without overclaiming compliance.

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What “regulatory alignment” means

Standards-conscious, audit-ready

Regulatory alignment means:

your operating model is standards-conscious,
verification and traceability controls are enforceable,
evidence outputs are audit-friendly,
and the system supports inspection-ready documentation.

Important note. Compliance depends on scope, implementation, integrations, and SOPs.

Core capabilities regulators and auditors look for

Four expectations

Identity governance

Unit-level or batch-level as needed.

Prevention of reuse and misuse

Single-use where required.

Chain integrity

Sequenced, permissioned, auditable events.

Evidence availability

Logs, reason codes, exceptions, exports.

Regulatory pages

Structured for buyer intent

US DSCSA

Drug Supply Chain Security Act alignment.

EU FMD

Falsified Medicines Directive alignment.

India

CDSCO, DGFT, GS1 traceability alignment.

Frequently asked

FAQs

How does DSCSA compliance work?: DSCSA compliance generally requires governed product identification and traceability evidence across supply chain events. TrusCodes supports alignment through lifecycle control, event integrity, and audit-ready records.
How to comply with EU FMD?: EU FMD contexts typically require verification of medicine authenticity and controlled handling of identifiers. TrusCodes supports alignment through backend verification, misuse prevention, and structured evidence.
What is CDSCO traceability?: CDSCO traceability commonly refers to India’s direction toward stronger drug supply chain visibility and identification practices. TrusCodes supports standards-conscious identity governance and audit-ready traceability evidence.

Decision block

If you are mapping verification and traceability controls to regulated supply chain expectations:

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