Serialization and UDI is expected to improve patient safety
Pharmaceutical serialization is the tracking and tracing of a prescription drug’s path through the supply chain. Unique Device Identification (UDI) is intended to assign a unique identifier to all medical devices to adequately identify medical devices through their distribution and use. Both systems present opportunities to improve efficiency, safety, and patient care. This is generally accomplished through automated, electronic means, and is legally required in many countries. It involves such company practices as recording, authenticating, maintaining and sharing accurate records of items prior to dispatching.
We can provide both the regulatory and compliance service, automation and IT infrastructure and project management to ensure the systems are well implemented. We plan, implement and lead UDI/Serialization projects. This includes executing the changes necessary for compliance with regulations, as well as incorporating UDI/Serialization processes into the quality management and production operations.