Services

Qualification and Validation

In the pharmaceutical industry, high demands are placed on quality and data integrity. To ensure that these requirements are met, we support the customer with our many years of GMP experience. Validation success 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 qualification and validation of automation solutions in the pharmaceutical environment based on customer requirements and our standardized concepts.

Our Services

  • Project support Q&V
  • Elaboration of validation concepts according to GAMP5
  • Application of consistent, transparent document management
  • Ensuring data integrity
  • Integration of project-wide change management
  • Creation of system-related risk analyses and test plans according to defined qualification phases
  • Integration into the customer concept

Consulting Q&V

  • Development of validation concepts over the entire plant lifecycle
  • Support in GMP-compliant implementation of CSV projects
  • Assessment & categorization of computerized equipment
  • Optimization of customer documents
  • Coordination of qualification activities
  • Monitoring and reporting of test phases including deviation management

Success Factors

  • Risk-based and efficient validation concepts based on experience from many years of cooperation with a wide range of international pharmaceutical companies
  • Project-accompanying qualification and implementation in conformity with authorities (e.g. FDA/EU)
  • Efficiency increase due to the use of templates as source documentation
  • Extensive and constantly up-to-date expertise through projects with renowned pharmaceutical customers and participation in working groups of NAMUR, ISPE and
  • GAMP DACH
  • GMP-savvy research and technical team