As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical devices manufacturers.
With our industry-leading consultancy comprised of a broad portfolio, we optimize manufacturing processes by developing tailor-made solutions according to your individual needs and time requirements. Count on us – we act global and local to unleash the potential of your business, today and tomorrow.
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.
Our specialists in the life sciences area define validation processes for your company, taking into account the latest directives to identify possible compliance risks.
As experts, we support you in conforming to regulatory standards at national and international levels. Our expertise is always practical and up-to-date.
Utilizing proven and tested processes for commissioning, qualification, and validation, our equipment and validation specialists expedite machine qualification and validate your equipment – and thus faster into production.
We support you in all phases of Werum PAS-X implementation and take over tasks such as qualification and validation. In this way, we can effectively ease the burden on your personnel during the introduction of MES.
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.
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.
We advise you independently. From the selection of the appropriate solution to its implementation, which can be done at one or multiple locations, through support for the ongoing operation of your MES.
We support you in every phase of the Werum PAS-X MES implementation. Within this framework, we relieve you of many tasks that you previously had to carry out yourself. That will make your work much simpler.
We offer you professional services to help with Master Batch Record (MBR) development and are happy to advise you concerning the best approach to drafting, creating, and checking high-quality MBRs for PAS-X.
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.
We analyze, define, and harmonize your business processes so you can unleash your full potential.
Our experts bring your Enterprise Manufacturing Intelligence (EMI) solutions to peak performance. Our consulting services in this area extend from data selection, analysis, and preparation in the form of reports and dashboards through validation.
The use of data ensures progress in the pharmaceutical, biotechnology, and medical products industry. Exact and complete data minimizes the risks to the safety of patients and your company. We support you according to your needs!
With comprehensive sector expertise and a practical orientation, we take on the responsibility for the smooth implementation of your production-related software project — whether it’s an individual project or part of a comprehensive program.
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.
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.
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.
We are your contact when it has to do with pharmaceutical products. As a leading system supplier, we advise you on everything from development through manufacturing and inspection all the way to the packaging of your products.
We have already established ourselves on the market in the area of consulting at the start of the 2000s. In the two decades since then, we have been a fixed part of the pharmaceutical and biotechnology industry. Our consultants are experts for questions related to production in the regulated industry, and they find perfectly fitting solutions for your requirements.