Production Management MES systems ensure compliance with regulations

Redakteur: Kathrin Schäfer

Manufacturing execution systems (MESs) ensure efficiency in production management. In iTAC.MES.Suite, Itac Software AG offers an MES specifically for medical technology that is designed to support conformity with regulations and with stipulations pertaining to compliance, QA and traceability.

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The MES guarantees conformity with ISO 13485 and FDA requirements.
The MES guarantees conformity with ISO 13485 and FDA requirements.
(Bild: Itac Software)

Among other things, having an MES essentially guarantees that the company will conform with ISO 13485 and FDA requirements and ensures seamless real-time transparency throughout the production process. Traceability, systemwide, also is guaranteed by means of the “active traceability” prevention strategy, which prevents errors.

At the same time, iTAC.MES.Suite simplifies quality management, making it unnecessary to use a variety of isolated solutions. The possibility of wholly paper-free production along the lines of the digital factory, including change of work flows by means of electronic and digital signatures, is a further attraction.

Detailed documentation

Among the other FDA-prescribed production management requirements is detailed documentation of all relevant processes and conditions. For every device, iTAC.MES.Suite compiles a Device Master Record, which highlights how the device is to be manufactured. In addition, the MES generates an electronic Device History Record for every individual item produced. The MES system thus eliminates laborious, paper-based data gathering and its high susceptibility to error.

For further information:

Itac Software AG

Dernbach, Germany