Nov 11, 2014
In the field of biomedical manufacturing, software innovation encounters uniquely challenging obstacles. Not the least of these are regulatory compliance requirements. Each step of a solution rollout must be rigorously planned, carefully executed, and painstakingly validated. Given the effort required to implement even a single suite of enterprise software in this environment, it is no wonder the industry has been slower to pursue multi-tiered integration initiatives. Such projects require a mindful analysis of interoperability options between a diverse array of hardware and software, and an experienced eye to identify potential gaps and redundancies as data flows between systems. For these reasons, it is critical that biomedical manufacturing enterprises carefully choose an integration partner with the particular skills and experience required for a successful and cost-effective rollout.
Engineering is proud to have been selected as the partner for such an integration at one of the world’s leading medical device manufacturers. Our consultants are leading a global effort to standardize the entire corporation on the new platform. This project will require the integration of a variety of production equipment and automated gauges to efficiently and reliably collect process parameters and critical quality attributes. The system must also integrate order data from ERP systems, link drawings and work instructions from source-controlled repositories, and trigger real-time responses in 3rd party MES packages, all while utilizing a single-source user authentication platform. The requirements are daunting. The opportunity, however, is thrilling. Through our industry experience and professionalism, Engineering is excited to contribute toward an initiative that will add enormous value to this manufacturing enterprise for years to come.
