TraceLink, the leading end-to-end digital network platform for intelligent supply chain orchestration, announced on July 23, 2025, the successful completion of its ISO 9001:2015 annual surveillance audit, now encompassing its OPUS Orchestration Platform for Universal Solutions. This milestone reinforces TraceLink’s commitment to delivering high-quality, compliant solutions for life sciences, healthcare, and pharmaceutical industries.
TraceLink expandsangono - TraceLink updates ISO 9001:2015 certification to include OPUS platform.
Validates robust quality management system (QMS) for scalability and compliance.
Supports GxP, SOX, and ISO 27001 requirements in regulated industries.
Complements existing certifications: ISO/IEC 27001:2022, 27017:2015, SOC 2, CyberVadis.
Enables no-code, cloud-based supply chain solutions with AI orchestration.
Connects 291,000+ entities via B2N Integrate-Once™ network for traceability.
The ISO 9001:2015 certification, achieved through a rigorous third-party audit, confirms that TraceLink’s QMS meets international standards for quality control, customer satisfaction, risk management, and continuous improvement. The expanded scope now includes OPUS, a no-code platform designed for Industry 4.0 solutions, enabling seamless integration and orchestration across complex supply chains. “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.
TraceLink’s certifications, including ISO/IEC 27001:2022, ISO/IEC 27017:2015, SOC 2 / ISAE 3000 Type II, and a top-tier CyberVadis rating of 946/1000, highlight its leadership in data security and compliance. These credentials ensure TraceLink meets stringent regulatory requirements like GxP and SOX, providing assurance for enterprises in highly regulated sectors. The OPUS platform supports over 291,000 healthcare and life sciences entities, offering global connectivity and traceability through its B2N Integrate-Once™ network.
The OPUS platform, recognized by CIOTechOutlook as a top 10 pharma and life sciences solution, enables no-code digitalization, reducing costs and enhancing agility. Its Magnum release (September 2024) introduced a no-code solution environment, universal integration, and AI-driven orchestration, addressing challenges like inventory management and regulatory compliance. TraceLink’s focus on AI-powered orchestration positions it to meet evolving supply chain demands, ensuring scalability and operational efficiency.
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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