Computer System Validation – Qualification for GAMP-compliant pharmaceutical technology
The laws and regulations of the Life Science industries require a structured and comprehensible procedure in their supply chain. For meeting these requirements, we support you in creating an appropriate quality managements 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 and goal-oriented future.
We consider the current national and international policies and guidelines and are guided by established standards and norms.
Computer System Validation – Our services
Our services, like the Compliance topics itself, are multilayered and include various aspects – ranging from the development of quality management systems, to validation and qualification, to IT management or software development for regulated industries.
We offer a broad range of different compliance management services:
- Quality management system
- Audit management and support
- IT validation and certification, tailored to your requirements and industry
- IT infrastructure management and network qualification
- Training seminar management and execution
- Tool implementation for QM or validation processes
- System and software development (Good Engineering Practices)
- Computer system validation (CSV)
Computer System Validation – Your benefits
Our employees are regularly trained and possess extensive work 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 your audits for an efficient quality management
- Compliance with all regulatory requirements for national and international guidelines
- Quality management with quality