Qualification & validation according to GAMP

The pharmaceutical industry places high demands on quality and data integrity. To ensure that these requirements are met, we support our customers with our many years of GMP experience. The success of validation depends not only on the technical design, but also on the presentation, implementation and communication of the topic. This is why we design a pragmatic and efficient implementation of the qualification and validation of automation solutions in the pharmaceutical environment based on customer requirements and our standardized concepts.

• Development of validation concepts according to GAMP5
• Evaluation & categorization of computerized systems
• Application of consistent, transparent document management
• SOP creation, implementation guidelines
• Ensuring data integrity
• Integration of project-wide change management
• Creation of system-related risk analyses, test plans and protocols in accordance with defined qualification phases
• Integration into the customer concept
• Internal GAMP training and project specifications
• Optimization of customer documentation
• Coordination of qualification activities
• Monitoring and reporting of test phases including deviation management