contractpharmaJanuary 25, 2017
Tag: Serialization Solutions , DSCSA compliance
Ropack Pharma Solutions has selected TraceLink to provide serialization solutions for its customers. Leveraging the TraceLink Life Sciences Cloud, Ropack’s international serialization hub provides an efficient and streamlined solution to assist its more than 130 pharmaceutical manufacturing customers prepare for the approaching serialization deadline in November 2017 to comply with the U.S. Drug Supply Chain Security Act (DSCSA).
The Ropack international serialization hub enables packaged pharmaceutical products to be sent by an organization’s in-house packaging team or contract partners to the Ropack facility. Using the TraceLink Life Sciences Cloud and Optel Vision, the packaged products are serialized, aggregated and then shipped with the appropriate complication documentation, to a distribution network or another warehouse.
"Serialization and regulatory compliance are complex process, but with TraceLink, it’s a simple connection that is low cost and managed entirely by their in-house experts. We selected TraceLink because it offers an easy-to-use platform that helps our customers achieve compliance without all the challenges and difficulties that pharmaceutical manufacturers often face when implementing a serialization program," said Paul DuPont, vice president of marketing and business development, Ropack. "Becoming serialization ready for DSCSA is a complicated, time-consuming and costly endeavor for all companies, large and small. Our international serialization hub, leveraging the TraceLink Life Sciences Cloud as a core component, reduces an organization’s capital expenditures, need for increased personnel and the multifaceted coordination required for serialization."
Shabbir Dahod, president and chief executive officer, TraceLink, said, "Time is crucial with the first DSCSA serialization deadline going into effect later this year. Companies ultimately need to master the complex DSCSA requirements, implement their solution to generate, store and manage unprecedented volumes of regulated data, and exchange that data with all of their supply chain partners. Complying with serialization is a daunting task that takes time, money and resources, and for companies that haven’t started yet, being ready by November 2017 may be unattainable."
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