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TraceLink Enhances Compliance with ISO 9001 Certification Update

In a significant advancement for businesses operating within regulated sectors, TraceLink, recognized as the largest digital network platform for intelligent supply chain orchestration, has successfully updated its ISO 9001:2015 certification. This achievement signifies a steadfast commitment toward ensuring high-quality, scalable, and compliant solutions that are essential for organizations such as those in life sciences, healthcare, and pharmaceuticals.

What is ISO 9001 Certification?

ISO 9001 is a globally recognized standard that outlines criteria for a quality management system (QMS). Achieving this certification indicates that an organization effectively meets customer needs and enhances customer satisfaction through consistent quality and improvement practices. TraceLink's successful completion of the annual surveillance audit demonstrates its adherence to these rigorous standards and reflects its ongoing commitment to quality.

The Importance of Certification for TraceLink

The recent expansion of the ISO certification scope to include OPUS, the Orchestration Platform for Universal Solutions, highlights TraceLink's dedication to delivering reliable services to its ever-growing client base. This certified platform supports organizations in navigating complex compliance requirements, including Good Practice (GxP) regulations, Sarbanes-Oxley Act (SOX), and other pertinent ISO standards.

Shabbir Dahod, President and CEO of TraceLink, emphasized the importance of this certification by stating, "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." The certification reassures customers that every aspect of their operations, from digital network integration to intelligent data and process orchestration, is developed under a robust, audited quality system.

Assurance in Regulated Industries

As more companies within regulated sectors seek to modernize operations via secure and trustworthy Software-as-a-Service (SaaS) solutions, the significance of ISO 9001 certification cannot be overstated. It provides an added layer of assurance, as quality systems integrated within TraceLink's offerings facilitate scalability and governance while mitigating operational risks. This is crucial for businesses striving to meet compliance mandates independently.

TraceLink's commitment to innovation is further reinforced through structured quality management processes, underpinned by extensive internal audits and corrective action frameworks. The company's dedication to maintaining high operational standards means that its platform developments align with top-tier industry expectations for quality and reliability.

Comprehensive Security and Compliance Achievements

This recent certification is part of a broader portfolio of TraceLink's security and compliance accolades, which include notable certifications such as ISO/IEC 27001:2022, ISO/IEC 27017:2015, SOC 2, and an exceptional rating from CyberVadis. Through these achievements, TraceLink solidifies its profile as a leader in data protection and solution dependability, catering to the compliance demands of both enterprise and public sector clientele.

For additional details on the complete array of TraceLink's certifications, interested parties can visit the official website at TraceLink Certifications.

About TraceLink

TraceLink Inc. stands as the premier intelligent supply chain platform for life sciences and healthcare. The company boasts a network connecting over 291,000 healthcare and life sciences entities through its B2N Integrate-Once™ network. The platform ensures that leading businesses can achieve full connectivity, visibility, and traceability of healthcare products, thereby guaranteeing that every patient receives the necessary medications safely and promptly.