COMPLEXITIES IN COMPLIANCE MADE SIMPLE WITH MODULAR MES

The medical device industry is often on the cutting edge of technology and innovation. Driven by explosive growth, the sector has become one of the largest in the world, with a market size of almost $150 billion. To excel in this highly competitive industry, Proteus needed a software solution that could unify their production workflows and unique processes.

The manufacturing operations at Proteus are complex and involve many processes that take place over a relatively long period of time. As production volumes grew, the use of manual, paper-based Device History Records became more and more burdensome.

Challenges:

• Creation of the Electronic Device History Record (eDHR), from a paper-based process consisting of 35 steps.
• Significant overhead in maintaining data. Mistakes were common in manual processes without verification systems in place.
• Compliance requirements with printed eDHRs.
• Hosted data system was not real-time and required manual entry of eDHRs.
• Solution had to address complex traceability issues as lots were grouped and then redefined for various processes.

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