Computerized System Validation Services
As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.
With our industry-leading consultancy comprised of a broad portfolio, we assess your current status against your ambitions and work with you to develop your path to exceptional product quality, high operational efficiency, and innovative practices 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.
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
Our specialists in the life sciences area define validation processes for your company, taking into account the latest directives to identify possible compliance risks.
Validation for the medical devices industry
As experts, we support you in conforming to regulatory standards at national and international levels. Our expertise is always practical and up-to-date.
Machine qualification
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.
Validation for PAS-X MES
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.
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.