Three pharmaceutical industry veterans with 80 years-combined experience were added to the growing life sciences roster at TraceLink Inc.
The three – Elizabeth Waldorf, Michael Ventura, and Marcel Zutter – have deep expertise in global serialization, product traceability, and supply chain transformation, and they are the latest to join a growing TraceLink team of 153 employees, which has increased by more than 80 percent since Jan. 1.
SSI Schaefer announced it has developed an automated solution, the SSI Order Verifier, to verify and document orders prior to shipping. The move is in response to the Drug Supply Chain Security Act and the new FDA regulations mandating distribution of pharmaceutical products require high-speed camera-based scanning, integrated with automated labeling to track and trace shipments.
The Steering Committee of the Open Serialization Communication Standard Working Group (Open-SCS) addressed compliance to healthcare counterfeiting regulations recently by announcing the accelerated development of an industrial interoperability standard and associated requirements templates for release by the end of 2015. The scope of work products focuses on healthcare packaging serialization interoperability across the plant’s equipment, systems, and between the supply chain systems.
The Federal Drug Administration released the document DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry. The guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
TraceLink Inc., a global largest track and trace network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, announced that United States wholesale distributors currently managing a mix of paper and electronic compliance documents under the U.S. Drug Supply Chain Security Act (DSCSA) can reduce their compliance infrastructure and labor costs by more than 70 percent in the first year as a TraceLink customer.
Optel Vision announced its launch of the first non-vendor locking site server, the Open SiteMaster, geared to improve data exchange for serialization without annual license fees.