At TrakCel, our mission has always been clear: to orchestrate the world’s most complex cell and gene therapies through secure, reliable, and compliant software that our customers can trust without hesitation. Today, I’m proud to share a major milestone in that commitment: TrakCel has successfully achieved ISO/IEC 27001 certification, the globally recognized standard for information security management systems (ISMS).
This achievement reflects not only the maturity of our processes and controls, but also our continued investment in protecting the highly sensitive data entrusted to us by our clients, their partners, and, ultimately, the patients they serve.
Also, this is a milestone that strengthens the foundations we need as TrakCel expands its offerings and deepens its capabilities as a system integrations (SI) partner, where robust data security will be critical to supporting increasingly complex digital ecosystems. As we continue to evolve, our role extends beyond software delivery; we are increasingly partnering with organizations as a trusted digital transformation partner, guiding them through the operational, regulatory, and data-security challenges unique to advanced therapies.
Why ISO/IEC 27001 Matters in Cell and Gene Therapy
Cell and gene therapy supply chains are among the most intricate in the world. They involve extensive personal data, chain‑of‑identity and chain‑of‑custody records, and collaboration across manufacturers, CROs, couriers, clinical sites, and treatment centers. Every one of those touchpoints must be protected by rigorous information security standards.
ISO 27001, published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), defines what “good” looks like for information security. It sets out how an organization must build, operate, and continuously improve a robust security management system capable of supporting highly regulated and data‑sensitive environments.
As TrakCel evolves to connect more platforms, partners, and data flows, maintaining a proven, independently validated security framework becomes essential to ensuring these integrations remain resilient and compliant.
Strengthening our security posture supports our broader ambition to act not only as a technology provider but as a strategic partner, offering expert consultancy that helps therapy developers build secure, scalable, and compliant pathways from clinical to commercial
For our customers, many of whom must meet escalating expectations from regulators, investors, and procurement teams, the certification is a clear signal that TrakCel operates to a globally recognized benchmark for security.
A Thorough and Independent Audit
Our ISO 27001 certification was performed by A‑LIGN, a leading, technology‑enabled security and compliance assessor trusted by more than 4,000 global organizations. A‑LIGN is accredited by both the ANSI National Accreditation Board (ANAB) and the United Kingdom Accreditation Service (UKAS) to perform ISMS certifications, ensuring the highest degree of independence and rigor throughout the audit process.
What made the process especially valuable was the opportunity to challenge and refine our own internal controls. As A‑LIGN’s COO, Steve Simmons, notes, organizations that embrace the audit process benefit from both expert insights and the assurance that their final certification reflects meaningful, operational security, not just documentation.
What This Means for Our Clients
Earning ISO 27001 certification isn’t simply a badge; it’s evidence of a company‑wide commitment to safeguarding information at every level and across every function. For TrakCel clients, this means:
- Stronger protection for sensitive data
From patient identifiers to manufacturing data, every element of your therapy program benefits from rigorously designed and independently validated controls.
- Increased confidence in third‑party risk assessments
Procurement and security teams increasingly look for ISO certification as a baseline requirement. Our certification streamlines vendor assessments and reduces the burden on your internal teams.
- Enabling secure integrations as our ecosystem grows
ISO 27001 provides a trusted security baseline for expanded platform capabilities, third-party integrations, and future SI partnerships- helping clients move faster while maintaining confidence in how their data is protected across all connected systems.
This certification also reinforces the trust our clients place in us as a digital transformation and SI partner, ensuring that every recommendation, integration, and workflow design is grounded in a proven and independently validated approach to data protection.
- Demonstrated commitment to continuous improvement
ISO 27001 is not a one‑time achievement; it requires an ongoing cycle of monitoring, review, and enhancement. This aligns with TrakCel’s approach to quality, compliance, and platform evolution.
- Assurance that security is built into the orchestration platform- not added on
Our information security processes support everything from software development and testing to hosting, access management, and business operations. Clients can be confident that security is foundational, not decorative.
A Milestone, And a Starting Point
For the team at TrakCel, this certification is both a moment of celebration and a reminder of the responsibility we hold. It also sets the stage for our next phase of growth, ensuring that as we broaden our offerings and expand into SI partnerships, every new capability is built on a secure, scalable, and continuously improving security framework. As cell and gene therapy continues to scale globally, so too must the resilience, transparency, and trustworthiness of the systems supporting it. As TrakCel strengthens its role as a digital transformation and systems integration partner, ISO 27001 provides essential assurance that every engagement, from platform enhancements to integrated ecosystem design, is grounded in a rigorous, security-first foundation.
We’re proud of this achievement, but more importantly, we’re proud of what it enables: uninterrupted trust from our clients, safer journeys for their patients, and a stronger foundation for the next phase of TrakCel’s growth.
Should you have any questions about our ISO 27001 certification, how it supports your therapy program, or what it means for your audits and due‑diligence processes, our team is always here to help.
Article by Minal Bhoja - 3 Mar 2026
Minal has over 10 years experience working in quality and compliance roles for pharmaceutical and Medical Device companies and adherence to a range of ISO standards including 9001, 18001, 14001 and 13485. Minal supports customer audits as well as advising our own team on audits and validation, CAPAs, change control and continuous improvement of the QMS. As CSV Lead, Minal is key to implementing the company Validation strategy at both a base product and deployed product level. It is this approach that allows our customers to leverage what we do to reduce the effort associated with demonstrating compliance.
