Automation in pharmaceuticals & biotech production and factory design
Integrating all relevant functional areas into the corresponding IT systems and automation components is the basis for an efficient design of complex production processes. This is the speciality of our Manufacturing IT team.
ioDigitalSolutions manages and coordinates all processes prior, during and after the implementation of your IT system – from specifications through to acceptance tests. This includes the interfaces to the ERP system (SAP and others) and the machines, to material flow control and to the laboratory equipment. We determine the specific requirements for the subsystems and help you select the best implementation partners for your specific needs.
From ERP to the machines: we plan and design individual automation solutions and ensure optimal compatibility between the IT systems across all levels of the production process.
We are a member of NAMUR, the International User Association of Automation Technology in Process Industries, that serves as a forum for regular knowledge and information exchange. As such, we can always offer our clients leading edge know-how to tap the potential of new value chains.
From risk analysis to performance qualification – validation with the MES experts: Production processes in the pharma industry are subject to extensive regulatory requirements. IT systems that influence product quality must be validated and require documented proof that they comply with the prescribed criteria. Companies therefore have to invest a lot of effort in the documentation, regardless of whether processes, equipment or software need to be validated.
With our team of experienced pharmaceutical planners and IT consultants, ioDigitalSolutions will guide you through the entire validation process. We always apply the V-model and follow the Good Automated Manufacturing Practice (GAMP) Guide and/or the guidelines of the Food and Drug Administration (FDA).
Manufacturing IT in detail
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