Exchange data without compromising compliance.

Veratrak is built specifically for regulated environments. Every data exchange is logged, validated, and traceable - meeting the requirements of the regulations that govern your supply chain.

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WHY IT MATTERS

The compliance problem with external supply chains

When companies share data with CDMOs, vendors, suppliers, and logistics partners, that data exchange is subject to GxP requirements - not just the data itself. The system facilitating the exchange must be validated, the data must have a traceable audit trail, and records must be attributable, contemporaneous, and permanently available.

Most companies manage this through email, SFTP, and manual reconciliation - none of which meet GxP data integrity requirements. Veratrak replaces that patchwork with a validated, purpose-built platform for supply chain data exchange.

REGULATIONS

What applies to your supply chain

The regulations that govern data exchange with CDMOs, 3PLs, distributors, and other supply chain partners.

Annex 11

Computerised Systems

Governs computerised systems used in pharmaceutical manufacturing and distribution. Applies to any system that creates, modifies, maintains, archives, retrieves, or transmits GxP-relevant data.

Veratrak: every data exchange is logged, timestamped, and attributed. All actions are retained in a complete audit log. IQ/OQ documentation available on request; PQ templates provided to support your own validation programme.

21 CFRR Part 11

Electronic Records

US equivalent of Annex 11. Establishes requirements for electronic records and electronic signatures in FDA-regulated environments. Mandates audit trails, access controls, and system validation.

Veratrak: all order, shipment, inventory, and document records maintain a full audit log. User actions are attributed with timestamps throughout. IQ/OQ validation documentation available on request.

DSCSA

Drug Supply Chain Security Act

US federal law requiring lot-level drug traceability across the full supply chain. Trading partners must be verified; transaction records must be exchanged and retained at each transfer of ownership.

Veratrak: shipment and order records support lot-level identification and chain-of-custody data capture. Speak to us about your specific DSCSA workflow.

GDP

Good Distribution Practise

EU guidelines for the wholesale distribution of medicinal products. Applies to wholesalers, 3PLs, and distributors. Requires temperature monitoring, chain of custody, complaint handling, and qualified person oversight.

Veratrak: shipment tracking includes carrier event logging with timestamps for chain-of-custody documentation. Where partners provide structured temperature output, this can be captured alongside shipment records.

ALCOA+

Data Integrity Principles

Mandated by MHRA, FDA, and WHO. Data must be: Attributable, Legible, Contemporaneous, Original, Accurate - plus Complete, Consistent, Enduring, and Available.

Veratrak: all data is attributed to source, timestamped on receipt, stored in original format alongside normalised versions. Permanently retrievable. Never overwritten.

ICH Q10

Pharmaceutical Quality System

Describes a comprehensive model for an effective pharmaceutical quality system. Requires documented processes, supplier oversight, and continuous improvement - including external manufacturers.

Veratrak: Supplier Performance module provides structured, data-driven supplier oversight consistent with the continuous improvement and supplier management principles of ICH Q10.

OUR APPROACH

How Veratrak meets these requirements

Compliance is built into the platform architecture - not a checkbox at the end of the project.

FULL AUDIT TRAIL

Every data exchange, user action, and system event is logged with timestamp and attribution. Records are immutable - nothing is overwritten or deleted. The audit trail is always complete and always available.

SYSTEM VALIDATION

Veratrak Hub is developed to GAMP 5 Category 4 standards. IQ and OQ documentation is maintained and updated on each release. PQ templates are provided to support your own validation programme. Full validation pack available on request.

ACCESS CONTROLS

Role-based access controls ensure users only see the data relevant to their role. All access is logged. User attribution is applied to every action - meeting the "Attributable" requirement of ALCOA+.

DATA LINEAGE

Original files from partners are stored alongside normalised records. The full processing chain - receipt, classification, transformation, delivery - is visible per transaction. No black boxes.

Trusted, validated, and award-winning, see the recognition behind our compliance → Explore our accolades

RELEVANT MODULES

Where compliance matters most

Every Veratrak module maintains a GxP-attributable audit trail. These modules are where compliance requirements are most direct.

Transaction Monitor

The ingestion layer. Every file from every partner is logged, validated, and traceable from receipt to delivery. The foundation for GxP-attributable data exchange.

Order Management

Every order event - creation, confirmation, update, fulfilment - is logged with full audit trail. Electronic order records meet 21 CFR Part 11 requirements.

See all →

Shipment Management

Carrier events and shipment records provide chain-of-custody documentation under GDP. Temperature logger data ingestion supported.

Speak to our compliance team

We'll walk you through the compliance architecture, validation documentation, and how Veratrak maps to your specific regulatory requirements.

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As a software company dedicated to enhancing the efficiency and security of the healthcare and pharmaceutical industry, we prioritise the protection and confidentiality of your data.