Both Serialization and UDI is expected to improve patient safety, modernize postmarket surveillance and facility innovation
Pharmaceutical serialization is the tracking and tracing of a prescription drug’s path through the supply chain from manufacturing to dispensing. 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. Patient safety is improved by helping to identify counterfeit products and improving the ability of staff to distinguish between drug and devices that are similar in appearance but serve different functions. 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.