In the field of medical technology, products which are used for the prevention, diagnosis and therapy of diseases are developed and manufactured. Digitalization has noticeable effects here as well - which are reflected, among other things, in growing data volumes and increasing demands on the IT infrastructure. Find out more about the challenges facing the industry and the advantages of using our software solution.
Industries in the area of medical technology and pharmaceutical manufacturing are characterized in particular by a high degree of innovation and an enormous price erosion, which results in a tremendous competitive pressure on the market. Due to strict specifications, manufacturers in these sectors and new medical technology innovations have a hard time entering the market.
Production in the pharmaceutical and medical industries is subject to strict regulations and requirements, which must be met. Standards and guidelines such as ISO EN 13485 or regulations from the Food and Drug Administration (FDA) such as 21 CFR Part 11 give concrete specifications which the used IT systems must fulfil. This ensures that every product is in perfect condition when it leaves the factory.
By using a production-related IT solution such as the iTAC.MES.Suite, the requirements for complete documentation and traceability can be met reliably and in compliance with guidelines. At the same time, the out-of-the-box MES solution always keeps your production in focus: increased efficiency and optimized machine utilization are just some of the effects that you can expect from using the iTAC.MES.Suite.
- Complete production process transparency in real time
- Higher productivity through optimized production processes
- Defect prevention with process interlocking and preventive strategies
- Batch and serial number tracking across all production stages
- Digital signature for paperless manufacturing
- Thoroughly compliant with all standards and requirements
- Seamless production history with complete electronic Device History records (eDHR)
Would you like further information on the many possibilities of the iTAC.MES.Suite in the area of medical engineering and manufacturing?
Contact our team of specialists with a broad spectrum of knowledge and expertise to discuss your requirements and how we can help you!