Codesplice Ltd: Leading the Future of Digital Compliance Innovation

Celebrating Excellence in Digital Innovation

Codesplice Ltd, a London-based software company with deep roots in the pharmaceutical and life sciences sectors, has been recognised with the SME500 UK – 2026 Award for Best Digital Innovation. This honour reflects the company’s commitment to delivering cloud-based compliance and quality management solutions that support regulated organisations in meeting stringent industry standards.

Purpose-Built Solutions for Regulated Industries

With decades of experience in the pharma industry, Codesplice has developed a suite of SaaS products engineered to simplify complex compliance requirements. These include TraxQM, Trax2D, TraxCM, and FMVerify—platforms designed to accelerate compliance, streamline operations, and embed regulatory expectations directly into everyday workflows.

TraxQM – A Risk-Based, Cloud-Based eQMS

At the heart of Codesplice’s offering is TraxQM, an electronic Quality Management System built using risk-based methodologies and aligned with global expectations such as ICH guidelines and ALCOA principles. The platform features tools for internal audits, CAPA, deviation management, change control and document handling through SharePoint Online integration. Its user-friendly interface, Kanban-based workflow and AI-supported intelligence provide immediate value for organisations seeking audit readiness and smarter quality oversight.

The system has earned endorsements from experienced ex-MHRA inspectors who recognise its ability to help wholesalers and manufacturers maintain a robust GDP-compliant QMS. This reinforces TraxQM’s credibility among organisations looking to reduce regulatory burden and address common inspection deficiencies through modern, cloud-based solutions.

Trax2D – Advanced Serialisation Compliance

Trax2D addresses EU EMVS serialisation requirements with precision, supporting both EPCIS v1.1 and v1.2 standards and offering seamless integration with CMOs. The platform ensures consistent data exchange and supply chain transparency—critical components for manufacturers, parallel importers and MAH holders operating in highly regulated environments.

FMVerify – Streamlined FMD Compliance

FMVerify provides a fully web-based approach to EU-FMD compliance, eliminating the need for local installations. With support for aggregation, Android devices and a wide range of scanner technologies, it simplifies compliance workflows and ensures full visibility across batch operations for pharmaceutical businesses.

TraxCM – A Cloud-Based ERP for Pharma

Built to meet the unique needs of wholesalers and parallel importers, TraxCM offers precise management of products, stock, sales and purchasing processes. Designed to integrate with NMVS for verification, decommissioning and recommissioning, TraxCM enhances control across box and pallet levels, paving the way for stronger supply chain compliance.

Engineering with Compliance at the Core

Codesplice’s applications are built using modern engineering principles and guided by regulatory experts. Their cloud-based solutions come with 99.9% uptime, follow GAMP5 guidelines and undergo regular security testing aligned with OWASP standards. These frameworks ensure customers benefit from reliable, scalable and secure platforms built to evolve with regulatory expectations.

Certified Quality and Trusted Expertise

The company is UKAS-accredited to ISO 9001 and ISO 27001, demonstrating its commitment to quality, security and operational excellence. This foundation supports organisations striving to unify data flows, improve documentation integrity and achieve continuous inspection readiness.

A High-Touch Service Model

Supported by a leadership team with extensive experience across technology, business management and consulting, Codesplice blends robust engineering with hands-on service delivery. Customers benefit from rapid implementation—often within days—alongside ongoing compliance support and bespoke development options tailored to meet individual organisational needs.

Driving Industry Growth Through Innovation

As pharmaceutical and life sciences organisations navigate increasingly complex regulatory landscapes, Codesplice continues to innovate by combining AI-driven risk assessment, smart process automation and user-centric design. This commitment empowers teams to work more efficiently, manage risk effectively and maintain continuous quality oversight.

Award-Winning Impact

Winning the SME500 UK – 2026 Award for Best Digital Innovation reinforces Codesplice’s role as a leading technology provider within regulated sectors. Their suite of risk-based, cloud-native applications demonstrates how modern engineering, paired with deep domain expertise, can transform compliance from a burden into a strategic advantage.

Conclusion

Codesplice Ltd stands as a trusted partner for pharmaceutical wholesalers, parallel importers and manufacturers committed to achieving operational excellence. As the regulatory environment continues to evolve, their solutions remain at the forefront—enabling organisations to stay compliant, prepared and confident in their quality and safety commitments.