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DSCSA Compliance for A.forall with Movilitas.Cloud
We helped a U.S. developer of generic prescription drugs comply with regulations for serialization and traceability.
Milla Pharmaceuticals, an A.forall company, is a developer of generic prescription drugs for the U.S. Pharmaceuticals & Life Sciences market focused on niche injectables and solution products for hospitals and clinics. Leveraging global partnerships with manufacturing facilities approved by the Food & Drug Administration (FDA), A.forall is on a mission to deliver high-quality medicines at affordable prices via a world-class supply chain.
Our team implemented Movilitas.Cloud, a comprehensive cloud-based serialization solution designed for ease of use and configuration. Utilizing its Serialized Manufacturing and Serialized Logistics applications, our Movilitas.Cloud team enabled A.forall to effectively manage serialization, aggregation, and compliance reporting while integrating seamlessly with their broader supply chain ecosystem.
To help the drug developer efficiently manage Serialized Manufacturing operations, our experts provided configuration support for Movilitas.Cloud. This included assigning unique serial numbers to individual product items, enabling batch traceability and managing aggregation processes to maintain visibility across multiple packaging levels. Movilitas.Cloud integrates seamlessly with CMOs, allowing real-time serial number exchange and commissioning details. Additionally, the platform facilitates automated in-line printing and serialized label generation, ensuring compliance with DSCSA standards while optimizing production workflows.
On the logistics front, Movilitas.Cloud's Serialized Logistics application provided A.forall with the tools necessary to manage shipment and warehouse operations for serialized goods. The platform supported automated responses to verification (VRS) requests and EPCIS generation for ownership changes, ensuring compliance with DSCSA-mandated traceability. Through integration with 3PL providers, the system enabled seamless tracking of serialized shipments, allowing the drug developer to respond to traceability requests in real time. By implementing secure file transport communication, our team ensured that critical serialization data could be exchanged reliably with logistics partners. This resulted in full end-to-end traceability, allowing A.forall to confidently distribute their first serialized products in the U.S. while meeting all regulatory requirements.
As regulations for serialization and demands for product traceability grow in size and scope, so will the value of integrated technologies for Track & Trace. The strong technical expertise, profound industry knowledge, and successful delivery record of our Movilitas.Cloud specialists make IndX a power player in the arena of serialized manufacturing and logistics. We will continue our mission for digital transformation to help industrial enterprises meet the demands of today’s dynamic economy.
