Reliability and compliance for pharmaceutical systems
In the pharmaceutical industry, comprehensive documentation and validation of technical systems is a key component of regulatory requirements. Our qualification services ensure that plants and IT systems comply with applicable guidelines – from design and implementation to operational approval.
We adhere to international standards such as GMP, GxP and GAMP and use structured testing processes and traceable documentation to create the basis for safe, stable and audit-proof operation. Our approach takes into account both technical functionality and regulatory integrity – and supports companies in ensuring quality and compliance in the long term.
Qualification
Whether you are introducing new production systems, digitising existing processes or validating computer-based applications, we support you through all phases of qualification with our expertise and industry knowledge.
- Planning, design and verification in accordance with official requirements (e.g. GMP, GxP, GAMP)
- Qualification
- Validation
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Computer System Validation (CSV)
Engineering Support – Project Support Services
From planning to implementation – we support your projects with technical expertise and a deep understanding of processes, quality and efficiency.
Find out more about our Engineering Support.