A significant element of process validation in the medical engineering and pharmaceutical industries is the technical review of individual plant and devices. This qualification is also required for Zwick materials testing systems used in the medical engineering and pharmaceutical industries, because systems are subject to various legal requirements (for example, under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11).
Other industries subject to regulatory compliance benefit from independent validation as well. If your industry regulations call for documented verification of processes, systems, and activities directly or indirectly related to product manufacture, you can rely on Zwick’s comprehensive qualification services to validate your testing program. The Zwick qualification portfolio of services delivers the complete spectrum of offerings to support regulatory compliance.
Zwick supports the qualification of materials testing systems in the DQ (design qualification), IQ (installation qualification), and OQ (operational qualification) processes by offering comprehensive and, if requested, individually tailored qualification documentation, as well as in the practical performance of qualification on site. Our experts work closely with you when planning qualification services.