Independent audit confirms TraceLink’s operational rigor and readiness to meet evolving customer and regulatory demands
BOSTON, July 23, 2025 /PRNewswire/ — TraceLink, the largest end-to-end digital network platform for intelligent supply chain orchestration, today announced the successful completion of its ISO 9001:2015 annual surveillance audit, expanding scope to include OPUS, the Orchestration Platform for Universal Solutions. The achievement reaffirms the company’s commitment to delivering high-quality, reliable, and continuously-improving solutions and platform capabilities for organizations in highly regulated industries, including life sciences, healthcare, and pharmaceuticals.
The ISO 9001:2015 certification, awarded following an extensive third-party audit by an accredited certification body, validates that TraceLink’s internal quality management system (QMS) meets the international standard’s rigorous requirements. This includes formalized processes for quality control, customer satisfaction, risk management, and continuous improvement across the organization.
A Trusted SaaS Partner for Regulated Industries
As companies in regulated industries look to modernize their operations with reliable and secure SaaS solutions, ISO 9001 certification provides customers with an added layer of assurance. TraceLink’s quality systems support scalability, governance, and operational risk mitigation, helping businesses meet their own compliance mandates, such as GxP, SOX, or ISO 27001 requirements.
“Expanding our ISO 9001 certification to include OPUS is a powerful affirmation of the reliability, repeatability, and quality-first processes that underpin TraceLink’s platform,” said Shabbir Dahod, President and CEO of TraceLink. “With more than 15 years of experience delivering solutions built to meet the rigor of GxP environments, customers can trust that everything from digital network integration to intelligent data and process orchestration is developed and supported under a robust, independently audited quality system. As OPUS evolves to meet increasingly complex supply chain needs—including agentic AI orchestration—it does so with the discipline and assurance of certified quality.”
Innovation Backed by Structured Quality
TraceLink’s certification reflects its process maturity in delivering no-code, cloud-based network digitalization capabilities via OPUS. Through robust internal audits, corrective action frameworks, and structured management reviews, TraceLink ensures that its platform innovation aligns with the highest standards of quality and reliability.
This expanded certification joins the portfolio of TraceLink’s global security and compliance achievements, including ISO/IEC 27001:2022, ISO/IEC 27017:2015, SOC 2 / ISAE 3000 Type II, and a top-tier rating from CyberVadis. Together, these certifications demonstrate TraceLink’s multi-dimensional leadership in safeguarding customer data, delivering dependable solutions, and meeting the compliance expectations of enterprise and public-sector buyers alike.
For more information on TraceLink’s certifications, visit tracelink.com/legal-and-trust/certifications-and-attestations.
About TraceLink
TraceLink Inc. is the largest end-to-end intelligent supply chain platform for life sciences and healthcare, enabling end-to-end orchestration by connecting more than 291,000 healthcare and life sciences entities through its B2N Integrate-Once™ network. Leading businesses trust TraceLink to deliver complete global connectivity, visibility, and traceability of healthcare products, ensuring that every patient gets the medicines they need when needed, safely and securely.
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