Healthcare & Life Sciences

Safeguarding medicine. Protecting patient lives.

Delta-X Trust delivers secure identity, serialization, and verification systems that ensure every healthcare product is accurate, compliant, and traceable from production to patient use.

Overview

Transforming healthcare with secure, intelligent identity ecosystems. Delta-X Trust closes the gaps between technology, compliance, and patient safety.

Benefits

Strategic solutions for regulated healthcare

Healthcare and life sciences demand absolute precision. From pharmaceuticals and clinical trials to medical devices and OTC packaging, every unit must carry accurate identity, compliant data, and a traceable history. Delta-X Trust unifies identity creation, line-level verification, site orchestration, and lifecycle intelligence so manufacturers, CMOs, and regulated partners can operate with confidence and protect patient safety at every step.

Advanced serialization
accuracy

Ensure every pharmaceutical unit receives a compliant digital identity aligned to GS1 standards, DSCSA, EU-FMD, SNDC, and national market requirements.

Integrated line-to-enterprise visibility

Move beyond siloed systems. Delta-X Trust links printing, inspection, aggregation, and enterprise data so healthcare teams can trace product movement with clarity from packaging to regulatory submission.

Intelligent risk
detection

Identify anomalies early. Real-time alerts flag misprints, mismatches, and diversion patterns before they escalate into compliance or safety issues.

Performance

Precision metrics driving healthcare technology forward

99.9%

Print and verification accuracy

Print and verification accuracy across machine-native Level 2 control environments.

0.001%

Code failure rate

Observed code failure rate in validated production settings using Tracker for in-line verification.

150+

Supported healthcare formats

Healthcare and life-science product formats supported across cartons, labels, vials, syringes, devices, and secondary packaging.

Capabilities

Healthcare technology capabilities

Delta-X Trust equips pharmaceutical, biotech, and medical-device manufacturers with a connected identity and data ecosystem designed for regulated environments. From serialization and in-line verification to compliance, data integrity, and cross-network traceability, each capability strengthens patient safety and operational accuracy across the entire healthcare lifecycle.

Compliance-ready product identity

Delta-X Trust generates secure, GS1-compliant identifiers aligned to DSCSA, EU-FMD, SNDC, and global pharmaceutical requirements. Codes are created with controlled rulesets, encrypted payloads, and full traceability so every serialized unit enters the supply chain with a validated, compliant digital identity.

Machine-native inspection and accuracy control

Tracker validates every printed identifier at line speed, detecting distortions, contrast issues, print anomalies, and placement errors before products move downstream. This ensures every medicine, device, or trial unit meets verification standards required by pharmacies, hospitals, wholesalers, and regulators.

Aligned with global regulatory frameworks

Our platform centralizes pharmaceutical compliance workflows through structured audit trails, validated data records, and 21 CFR Part 11–ready controls. Delta-X Trust supports DSCSA, EU-FMD, UDI, and SNDC reporting requirements, helping manufacturers and CMOs maintain consistent, audit-ready operations across markets.

Validated data across every lifecycle stage

Healthcare operations depend on trustworthy, unbroken data. Delta-X Trust enforces data validation across printing, inspection, aggregation, and enterprise integration. Every event is logged, verified, and protected to ensure pharmaceutical and device records remain accurate, complete, and compliant.

Early detection of operational and compliance risk

Insight surfaces anomalies and deviations early—flagging misprints, equipment variances, data drift, or repetition patterns before they impact patient safety or regulatory compliance. Healthcare teams gain predictive visibility that reduces rework, downtime, and downstream investigation effort.

End-to-end traceability across regulated networks

Delta-X Trust delivers full visibility across manufacturers, CMOs, 3PLs, dispensaries, and healthcare delivery points. With GS1 2D and Digital Link compatibility, product scan events become authenticated insight—supporting verification, recalls, cross-border compliance, and controlled product movement.

Solutions

Integrated healthcare solutions

Delta-X Trust supports the complete healthcare packaging and serialization ecosystem with aligned, regulatory-grade solution pillars.

Solution 1

Serialization & Identity Governance

GS1-compliant identity generation, encrypted payloads, and controlled rulesets designed for global pharmaceutical and device regulations.

Solution 2

Clinical Trial Packaging
Control

Support for subject-specific kits, blinded variation, investigator-site versions, and traceable chain-of-custody workflows

Solution 3

Medical Device UDI Compliance

Validated device identifiers, verified print application, and lifecycle records structured for UDI and post-market surveillance.

Solution 4

OTC & Regulated Packaging Accuracy

High-fidelity print and verification controls designed for safety-critical packaging where mislabeling carries patient risk.

Solution 5

Partner & Supply-Chain Synchronization

Ensure CMOs, 3PLs, and distribution partners operate with aligned identity rules, data models, and reporting.

Regulatory alignment

Regulatory frameworks for healthcare

Delta-X Trust provides validated identity workflows, audit-ready documentation, and structured data models that align with DSCSA, EU-FMD, SNDC, UDI, and 21 CFR Part 11 standards. Our platform ensures manufacturers, CMOs, and supply-chain partners maintain consistent compliance across every market they serve.

Intelligent data management protocols

Support for DSCSA, EU-FMD, SNDC, UDI, and global serialization frameworks through validated identity and structured data management.

Secure documentation & validation systems

IQ/OQ/PQ-ready workflows, change control, audit trails, and controlled documentation aligned with 21 CFR Part 11.

Precision that protects patients

Strengthen healthcare operations with trusted identity systems, verified data, and regulatory-grade workflows.

Healthcare & Life Sciences FAQs

This section addresses common questions from pharmaceutical, biotech, medical-device, and healthcare packaging teams evaluating Delta-X Trust for regulated environments.

How does Delta-X Trust support DSCSA, EU-FMD, and other serialization regulations?

Delta-X Trust generates GS1-compliant identifiers, controls how those identities are allocated and applied, and records the related production and verification events. This helps you align with DSCSA, EU-FMD, SNDC, and other market requirements for product identity and traceability. The platform is designed to support audit-ready records, structured data exports, and consistent identity usage across lines and sites. It does not replace your legal or regulatory obligations but strengthens the data backbone you rely on to demonstrate compliance.

Can Delta-X Trust integrate with CMOs, 3PLs, and clinical trial partners?

Yes. Delta-X Trust is built to coordinate identity and event data across internal sites and external partners such as CMOs, 3PLs, and clinical trial organizations. Shared rulesets, controlled identity pools, and secure data exchange help keep every partner working from the same source of truth. This reduces manual reconciliation, lowers the risk of data drift, and improves the reliability of downstream reporting.

Does the platform support blinded and subject-specific clinical trial packaging?

Delta-X Trust can support blinded, subject-specific, and investigator-specific packaging by linking controlled identity sets to defined trial rules. Packaging teams can manage variations, kit structures, and labeling logic while preserving blinding where required. All events related to printing, verification, and movement can be recorded to support chain-of-custody and trial documentation. Final study design and regulatory acceptance remain under the control of your clinical and QA teams.

How does Delta-X Trust help with data integrity and 21 CFR Part 11 expectations?

The platform is designed with validated data flows, event logging, and controlled user access to support data integrity in regulated environments. Identity-related actions and production events can be captured with timestamps, user references, and change history to create robust audit trails. These capabilities help you align with 21 CFR Part 11 expectations for electronic records and signatures when implemented within your validated quality system. Your QA and validation teams retain responsibility for defining and approving the overall validation approach.

Can Delta-X Trust scale across multiple sites, product families, and markets?

Yes. Delta-X Trust is designed to support multi-site, multi-line, and multi-market deployments where identity rules and packaging logic must stay consistent. Central governance allows you to define global standards while still adapting to local regulatory or market needs. As your portfolio expands, new product families and regions can be brought under the same identity and verification framework, reducing complexity instead of adding to it.