Rechon Life Science AB addresses new and future market regulations with Adents serialization solution to guarantee DSCSA and EU FMD compliance
Rechon Life Science AB, contract and development manufacturing organisation (CDMO) and producer of specialty pharmaceuticals, implemented Adents Seriza, a fully configurable and customizable serialization system from Adents, a leading provider of versatile and easily deployable serialization and track & trace solutions at their Sweden location to ensure compliance with the EU FMD and DSCSA for all Rechon’s customers in Europe and North America. Adents serialization solution is hardware agnostic, meaning it is compatible with a wide range of equipment which was a key selling point for Rechon
The Adents serialization and aggregation suite enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimizing impact on production processes and productivity.
While searching for a serialization solution that would ensure compliance with the DSCSA and the FMD, Rechon also sought a means of easy integration with the company’s Enterprise Resource Planning (ERP) system, and more importantly aggregation for the US market.
Additionally, Rechon also wanted to be able to address new market regulations and connect with L4 solution systems of their customers.
Adents serialization solutions are designed to help companies gain simplified speed to compliance with regulatory requirements.
Adents Seriza has met and continues to meet all of Rechon’s needs. The Adents serialization and aggregation suite of software enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimizing impact on production processes and productivity. An ideal “standardized software” approach, Adents software is extremely flexible, scalable, and quick to deploy because its configuration takes place completely at the site level, making per-line configuration unnecessary.
“We initially chose Adents Seriza because of its transparent total cost of ownership, and because it can adapt to any future regulatory changes, said Maria Wingren, Head of Projects & Validation, Rechon. We continue to be impressed with a powerful solution that allows us to address new markets and onboard new clients while receiving high quality advise and support from the Adents team.” continued Wingren.
“We are pleased that Rechon Life Science AB continues to use Adents Seriza to comply with upcoming serialization deadlines,” said Christophe Devins, CEO of Adents, “and are confident that the flexibility and adaptability of Adents Seriza will continue to help Rechon to move beyond compliance and improve business practices.”
Rechon Life Science AB is a developer and producer of pharmaceuticals specializing in aseptic injectables and sprays for nasal and oral administration helping their customers bring their products to market more quickly and at a lower cost.
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