"The production of medical products is governed by strict regulations and requirements. In addition, the new Medical Device Regulation (MDR), which became effective in Europe in 2021, imposes even higher standards for the QM system of medical technology companies and increases the pressure. This requires appropriate strategies and solutions on the manufacturer side in order to be able to withstand the increasing regulatory requirements in the market and to compete effectively," explains Martin Heinz, management board of iTAC Software AG.
Compliance: Manufacturing according to regulations
MES/MOM solutions reliably support seamless documentation and traceability in medical technology production and ensure compliance with regulatory guidelines. For example, processes such as the installation of components with serial numbers or the use of test equipment during production must be documented in detail and the corresponding requirements must be met.
"Without a supporting MES, all steps in the production of a medical device are processed and documented on paper. In the production of blood analysis instruments, for example, each work step and each component must be recorded on paper documents, which are then integrated into a manual and time-consuming approval process. If the test requires any necessary rework, this also must be documented manually again and all documents have to be archived afterwards, which can delay the entire manufacturing process by weeks," explains Martin Heinz.
The iTAC.MOM.Suite is a holistic manufacturing management system that provides all the necessary features for digital worker management, process automation and traceability of serialized products in a validated manner. The MES/MOM solution is used in production facilities in the pharmaceutical and medical industries to meet the specific requirements of international and national standards and guidelines and to guarantee the market a flawless, safe product.
With features such as material management including setup control, process interlocking, tool and test equipment management – embedded in a worker management system – the iTAC.MOM.Suite ensures that production only conforms to specifications and that all specified work and test steps are actually carried out. This reduces the time and effort required for approval processes, subsequent assembly and repairs.
Identify and eliminate quality problems in real time
"With Active Traceability, our MES/MOM solution ensures that quality problems in the production processes can be detected in real time, causes can be analyzed and corrective measures can be systematically and promptly evaluated in a continuous improvement process. All production information is made available to the worker in the process in real time. In addition, this data is provided in different levels of aggregation to various functional areas of a company – even up to the management level.
In the event of a callback, the product, including batch and serial numbers, can be traced back from the manufacturer to the customer. What is considered a standard function in the iTAC.MOM.Suite represents a decisive competitive function for medical manufacturing companies," explains Martin Heinz.