Streamlined Qualification: reduce formalism, boost benefits – efficient GMP compliance for new construction and reconstruction projects

Reducing qualification effort. Moderate and far-seeing. gempex offers support here with the new “Streamlined Qualification” service package. Not only is the conception of the qualification taken over but, if desired, also the management and key execution steps. Full service!

Based on extensive practical experience and established know-how regarding the technology and requirements, gempex supports the pharmaceuticals and chemicals industry in realising GMP compliance – moderate and with foresight and expert knowledge. All requirements of the DQ, IQ, OQ and PQ phases are unerringly met, and only truly essential documents are created in the project. The aim is to reduce the qualification effort to the essentials, establish clarity and avoid duplicate work.

Integrated project management is the key with the use of meaningful tools and instruments, but in particular the early, targeted integration of all participating trades. That saves resources, time, the budget and: nerves!

Additional benefits for the customer: 

  • Simplified, optimised qualification
  • Integrated project management, including engineering and qualification services
  • Use of proven tools and instruments
  • Integration of technical tests into qualification
  • Meaningful risk analyses to reduce effort
  • FAT and SAT documents suitable for qualification 
  • Comprehensive time, cost and quality control
  • Appropriate and timely integration of the trades
  • Guaranteed regulatory (GMP) compliance

 

For further questions please do not hesitate to contact us! 

info@gempex.com 
+49 621 819119-0