The independent audit confirms the operational rigor of Tracelink and the preparation for the realization of the evolving requirements of customers and regulatory
BOSTON,, July 23, 2025 / Prnewswire / – TracelinkThe largest digital network platform from start to finish for the orchestration of the smart supply chain, announced today the successful completion of its ISO 9001: 2015 annual surveillance audit, extending the scope to include OPUSThe orchestration platform for universal solutions. The realization reaffirms the commitment of the company to provide high-quality, reliable and permanent platform solutions and capacities for organizations in highly regulated industries, including life sciences, health care and pharmaceuticals.
The ISO 9001: 2015 certification, awarded following a large third -party audit by an accredited certification organization, validates that the Internal Management Management System (QMS) meets the rigorous requirements of the international standard. This includes processes formalized for quality control, customer satisfaction, risk management and continuous improvement through organization.
A SaaS trusting partner for regulated industries
While companies in regulated industries seek to modernize their operations with reliable and secure SaaS solutions, ISO 9001 certification offers customers an additional insurance layer. Tracelink quality systems support scalability, governance and attenuation of operational risks, helping companies respond to their own compliance mandates, such as GXP, SOX or ISO 27001 requirements.
“The expansion of our ISO 9001 certification to include opus is a powerful affirmation of reliability, repeatability and advantageous quality processes underlying the tracelink platform,” said Shabbir DahodPresident and chief executive officer of Tracelink. “With more than 15 years of experience providing solutions designed to meet the rigor of GXP environments, customers may believe that everything, from the integration of the digital network, intelligent data and processes orchestration is developed and supported in a quality chain of the robust and independently.
Innovation supported by structured quality
Tracelink certification reflects its maturity of processes in the supply of network digitization capacities based on cloud and cloud -based via opus. Thanks to robust internal audits, corrective action frames and structured management reviews, Tracelink guarantees that the innovation of the platform aligns with the highest standards of quality and reliability.
This enlarged certification joins the portfolio of the world’s safety and compliance of tracelink, including ISO / IEC 27001: 2022, ISO / IEC 27017: 2015, SOC 2 / ISAE 3000 Type II, and a leading note from Cybervadis. Together, these certifications demonstrate the multidimensional leadership of Tracelink in the backup of customer data, the supply of reliable solutions and the satisfaction of the expectations of compliance of business buyers and the public sector.
For more information on tracelink certifications, visit Tracelink.com/legal-and-trust/certifications-and-stestations.
About tracelinks
Tracelink Inc. is the largest intelligent supply chain platform from start to finish for life sciences and health care, allowing end-to-end orchestration by connecting more than 291,000 health care and life science entities via its B2N integration-once ™ network. The leading companies trust the tracelink to offer complete global connectivity, visibility and traceability of health products, ensuring that each patient obtains the drugs he needs if necessary.
Source Tracelink, Inc.
