Slim qualification - available as full service upon request

Reduce the effort of qualification. With measure and prudence. The GMP service provider gempex GmbH offers support here with the newly developed service product "Lean Qualification". If desired, not only the conception of the qualification is taken over, but also the management and key steps of execution.

Based on extensive practical experience and solid know-how regarding technology and requirements, gempex supports the pharmaceutical and chemical industries in achieving GMP compliance — with measure, foresight, and expertise. All requirements of phases DQ, IQ, OQ, and PQ are reliably fulfilled, only truly necessary documents are newly generated in the project. The goal is to reduce the effort of qualification to what is necessary, to create clarity, and to avoid duplication of work. The key lies in holistic project management, the use of meaningful tools and instruments, but especially in the early, targeted involvement of all participating trades. This conserves resources such as time, budget, and nerves.

Additional benefits for customers:

- Simplified, optimized qualification
- Holistic project management with integration of engineering and qualification services
- Use of proven tools and instruments
- Integration of technical tests into qualification
- Sensible risk analyses to reduce effort
- Qualification-ready FAT and SAT documents
- Comprehensive time, cost, and quality control
- Proper and timely involvement of trades
- Ensured regulatory (GMP) compliance