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Validation consulting
Our computerized system validation (CSV) experts support you in complying with regulatory standards at national and international levels.
Minimizing business risks, stable manufacturing processes, and product safety are good reasons why the validation services from Körber are important for regulated companies in the pharmaceutical, biotechnology, and medical technology industry.
Validation for pharmaceuticals biotechnology
Validation for the medical devices industry
Machine qualification
Validation for PAS-X MES
Line-Optimization and Guided Workflows
Optimize production and make best possible use of your machine data with our line optimization solution. Harmonized interface are part of it as well. Digitize the format change and line clearance process chains using our guided workflows based on modern augmented reality solutions. It’s completely paperless, including the GMP documentation that is required.
Manufacturing Execution System consulting
We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.
The vertical planning data of the company level and the horizontal machine data of the production level must be linked as part of digitization. These integration concepts are just one aspect of our MES solutions, about which our experts will comprehensively advise you.
Independent consulting and implementation for MES
Master batch record design and support for PAS-X MES
Manufacturing Operations Management consulting
Our experts for Manufacturing Operations Management (MOM) consulting pose the key questions in Business Process Management: “Who does what, when, how, and using what?” Our answers are always made to measure and have one objective — to develop on-schedule, on-budget, and high-quality solutions for your company.
What’s more, we also offer comprehensive and innovative solutions for your data management. Your processes are optimized in several ways by using flexible systems and allow operations to be more cost-effective.
Business Process Management
Data & analyses
Data integrity
Software implementation
Track & Trace consulting
Our experts provide you with knowledgeable advice during every phase of a Track & Trace project, starting with the initial analysis and definition of the requirements (e.g. serialization, aggregation), incorporating the selection of systems and vendors, and extending to implementation. Regardless of whether it’s a matter of complete and partial projects or narrowly defined individual tasks, we are prepared to deal with all project scenarios and take responsibility for providing professional, on-budget, and on-time services.
Track & Trace consulting
Our experts provide you with knowledgeable advice during every phase of a Track & Trace project, starting with the initial analysis and definition of the requirements (e.g. serialization, aggregation), incorporating the selection of systems and vendors, and extending to implementation. Regardless of whether it’s a matter of complete and partial projects or narrowly defined individual tasks, we are prepared to deal with all project scenarios and take responsibility for providing professional, on-budget, and on-time services.
Supply chain management consulting
For us, supply chain management consulting means holistically analyzing the regulated industries in various project phases. The complete material flow is examined from receipt to dispatch of the finished goods and improved, e.g. by components such as an efficient Warehouse Management System (WMS). And these components must adapt rapidly and cost-effectively to new regulatory requirements and processes. We’ll be happy to advise you.
Supply chain management consulting
For us, supply chain management consulting means holistically analyzing the regulated industries in various project phases. The complete material flow is examined from receipt to dispatch of the finished goods and improved, e.g. by components such as an efficient Warehouse Management System (WMS). And these components must adapt rapidly and cost-effectively to new regulatory requirements and processes. We’ll be happy to advise you.
CMC Statistical Consulting
Would you like to know how to successfully validate your processes, achieve regulatory filing and further improve the quality of your products? Use our process knowledge and statistical toolbox to gain deeper insights into your processes.
CMC Statistical Consulting
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