The next wave of Global Unique Device Identification Database (GUDID) compliance deadlines, the latest for labels and packages of all implantable, life-supporting, and life-sustaining medical devices, is now in the rear view mirror and we felt revisiting some tips for analyzing the efficiency of your GUDID compliance system would be useful singulair drug.
We all know that the Unique Device Identification (UDI) labeling and reporting requirements were put in place to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. The operational challenges of UDI compliance however, are many. Integrating the disparate data streams from the supply chain, enterprise resource planning (ERP), laboratory information management and production line manufacturing execution systems is an enormous undertaking.
If you have taken the time to put an integrated strategy into place for UDI data management, you are likely right on track with compliance deadlines and avoiding negative audit findings in the future. If you are still wrangling with manual methods of compliance, you are likely stressing over current and future impacts of UDI management on your business. Perhaps it’s time to rethink installing a more comprehensive solution. Whether manual or automated, your system must have the following elements:
- Flexibility. GUDID formatting requirements can be a nightmare if your system isn’t flexible. If the system you are using can’t stay abreast of changes in reporting requirements, you will inevitably face slowdowns and errors.
- Scalablity. Creating a system that is scalable for expansion or changing demands is a must if you want to keep your reporting on track in the process.
- Easy integration. If your data doesn’t easily integrate with the GUDID system, you will be spending a lot of unnecessary time and energy compiling and converting.
- Automated workflow. Getting the right information to the right staff members for review and approval can speed up validation, accuracy and ultimately facilitate smooth GUDID compliance.
How’s your medical device manufacturing company doing with GUDID compliance? We’d love to hear what you’ve done to get your business on track and help with finding solutions to your GUDID reporting problems.