Process Changes and Quality Control for Medical Device Manufacturers

Process Changes and Quality Control for Medical Device Manufacturers

By January 10, 2018 Blog No Comments

When we talk about managing process changes in an environment using MES the first benefit we see is the environment already has tighter controls in place. This means the process of changing our environment has to be more tightly controlled.

The second key element is the process changes are enforced. This prevents an operator from reverting to a previous method, tool, or material. An operator that hasn’t been trained on the new operation, is restricted from continuing the manufacturing process.

A strong validated MES is one that has been configured to include key data collection, well defined specifications, and a complete product workflow. A strong validated MES, can provide more effective real-time enforcement and make training simpler.

The ultimate goal of a paperless manufacturing solution is to have compliance be a by-product of operational excellence. Because MES can maintain device history in real-time, you are able to provide batch history records and/or device history records quickly and efficiently. Beyond the BHR and DHR, MES provides greater visibility into the history of manufacturing. Unlike a paper solution, your stored information is structured. From structured information a variety of reports can be generated on demand. Reports such as preventative maintenance, operator training, and non-conformance resolutions. All of this information becomes very valuable when showing your process well defined and followed.

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