QUALIFICATION FOR GAMP-COMPLIANT PHARMACEUTICAL TECHNOLOGY.
Computer System Validation
The laws and regulations of the Life Science industries require a structured and comprehensible procedure in their supply chain. In order to meet these requirements, we support you by creating an appropriate quality management system (QMS) as part of our computer system validation and certification.
Based on many years of expertise in the field and validation of computerized systems in the pharmaceutical industry, we offer you comprehensive compliance management services. We advise, support, and integrate solutions in goal-oriented manner.
We use the latest national and international directives and guidelines and are guided by proven standards and norms.
Like the compliance topics themselves, our services are multi-faceted and include various aspects – ranging from the design of quality management systems, IT validation and qualification to IT management or software development for regulated industries like the pharmaceutical sector.
We offer you a broad portfolio of different compliance management services:
- Quality Management System (QMS)
- Audit management and support
- IT validation and certification, tailored to your requirements and industry
- IT infrastructure management and network qualification
- Training management and implementation
- Tool implementation for QM or validation processes
- System and software development (Good Engineering Practices)
- Computer System Validation (CSV)
Our employees are regularly trained and possess extensive practical experience in different industries and organizations. This creates a wide range of benefits for you:
- Compliance with current acceptance criteria of the pharmaceutical industry for computerized systems
- Planning and support of your audits for an efficient quality management
- Compliance with all regulatory requirements for national and international guidelines
- Quality management with quality