Press release - HERNDON, VA - June 6, 2014
Rx-360, a not-for-profit international consortium representing the world’s leading pharmaceutical and biotech organizations, is committed to protecting patient safety. Recognizing that the globalization of suppliers has added significant complexity to ensuring supplier quality and security of the supply chain, Rx-360 has developed the Joint Audit program to verify and validate supplier compliance, enhance supply chain integrity and improve quality.
This innovative approach will allow multiple companies working with the same business partner to participate in a standardized audit without sacrificing product or process confidentiality. This in turn will significantly reduce audit costs, standardize the audit scope, expand the number of audits conducted, and ultimately reduce supplier audit fatigue while maintaining a high quality standard. The Joint Audit program will ensure audit consistency and transparency from audit scheduling through the required Corrective and Preventive Actions.
BSI was selected for this engagement following a thorough RFP process that considered more than a dozen other highly-qualified auditing firms. Rx-360 has chosen a partner in BSI that has proven its commitment to patient safety through its extensive work in the medical device industry.
With over 70,000 clients worldwide and more than 150,000 audit days in 150 countries per year, BSI has the resources and infrastructure required to assist Rx-360 with their audit needs and is perfectly positioned to serve as a partner with Rx-360 members’ supplier base.
BSI will utilize its Supplier Verification (VerifEYE) services which will provide local personnel familiar with the local language, customs and traditions to conduct the audits. To ensure consistency of audits, these auditors will be trained by BSI Supply Chain Solutions to standards specific to Rx-360 members’ auditing requirements, including cGMP regulations as well as supply chain security.
Dan Purtell, Senior Vice President, Supply Chain Solutions stated, “By incorporating BSI’s extensive history of corporate auditing, our reputation in the medical device community for patient-safety, and our cutting-edge risk-based approach to supply chain security, we are able to offer Rx-360 a unique solution to meet their needs for efficient and comprehensive supplier auditing. This award will help Rx-360 members significantly reduce ineffective and overlapping audits while maintaining the overarching goal of increasing patient safety.”
Ben Mills, Co-Chair of Rx-360’s Audit Operations Group stated, “Rx-360’s primary mission is to ensure patient safety by maintaining high standards of quality during the manufacturing process. The Joint Audit program will allow consortium members to pool resources and have third-party audits conducted simultaneously while protecting commercially-sensitive and proprietary information. With BSI Supply Chain Solutions, Rx-360 has a partner known for experience, confidentiality, and quality. BSI’s risk-based approach to auditing will enhance effectiveness and supply chain security. The Joint Audit Program offers consortium members, suppliers and manufacturers alike, the opportunity to reduce the audit burden while amplifying product confidence and safety.”
BSI’s integration into Rx-360’s Joint Audit program will begin later this summer.
Rx-360 was formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the supply chain. The mission of Rx-360 is important in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360 go to www.Rx-360.org.
About BSI Supply Chain Solutions:
BSI’s Supply Chain Solutions group helps organizations and governments mitigate business risk at every point of the value chain, whether brand protection, transit of goods, business continuity, or security compliance. We focus on supporting the overall integrity of our clients’ supply chain, providing timely world-wide information, leading edge tools, and best practices from over 100 years of experience. BSI unites professional advisory services with unique technology and automation, on-site supplier audits, and proprietary risk data and analytics to help companies effectively identify, assess, and mitigate risks that threaten the global supply chain and enterprise as a whole. No matter the global supply chain concern – social responsibility, intellectual property, cargo disruption, political instability, counterfeit goods, or compliance – BSI has developed a proven portfolio that can address today’s emerging supplier and supply chain risks. BSI Supply Chain Solutions is the only firm that infuses rich intelligence into a company’s supply chain risk management program.