Critical Manufacturing releases Medical Device case study

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Critical Manufacturing releases Medical Device case study

MES allows Medical Device Manufacturer to increase Compliance, Efficiency and Control

Critical Manufacturing releases Medical Device case study

4 Sep 2012

The customer is a top multinational company producing Medical Device products. The MES implementation in this case study was deployed at a US site initially developing product and processes for fabricating complex imaging devices. The facility produces a product family, whose manufacturing includes semiconductor, flat-panel and discrete processing steps.

The company defined the implementation of a Manufacturing Execution System as a strategic Quality and Lean measure. While having all the necessary flexibility to model a variety of manufacturing environments from the simplest to highly complex operations, the implementation at this Medical Device facility provided a tight product and process control, reducing variability and increasing traceability, enabling solid support for compliance of FDA titles 21 CFR Part 11 and 820.

In addition, cmNavigo productivity suite provided an extensive toolset that allows the company to continuously drive efficiency, yield, and throughput and deliver reliability increases.

According to customer’s MES Project Lead:

“Many of us have worked with older proprietary systems in the past where solution specialists had to make changes to deliver the incremental functionality we needed. This introduces not only a continual source of frustration, but also a maintenance cost burden.”

“In the area of compliance, we have been able to make a step change in terms of efficiency and control[…] Meeting our compliance obligations proved to be much simpler with a completely new solution than one might imagine.”

“We have not got to the bottom of what one can produce in terms of canned reports. Aside from that, 95% of what we ask for can usually be done with the standard product. This is a really big deal for us.”