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.
- 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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