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Qualification service (DQ / IQ / OQ) for the medical and pharmaceutical industries

DQ IQ OQ qualification service for the medical and pharmaceutical industries

Qualification of materials testing systems

 

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, as such systems are subject to various legal requirements (e.g. under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11).

The Zwick Qualification Service includes:

  • consulting
  • Design Qualification (DQ) with Functional Design Specification (FDS), Hardware Design Specification (HDS) and Software Design Specification (SDS)
  • qualification with Installation Qualification (IQ) and Operational Qualification (OQ) of the testing system
  • re-qualification of existing Zwick materials testing machines.

Zwick provides support for customers in the DQ, IQ and OQ qualification stages for materials testing systems in the form of comprehensive, individually tailored qualification documentation in accordance with GAMP5 and current guidelines, and during the actual on-site qualification procedure.

The modular documentation is modified individually by Zwick to conform to the configuration of the Zwick testing system. All documents are additionally checked and approved by Zwick and must be authorized by the system operator before qualification is carried out. Experienced, specially trained Zwick service technicians carry out the qualification step-by step on-site at the customer's premises using the qualification documents previously generated.

Advantages for users of Zwick materials testing machines:

  • modular qualification package, consisting of either the complete DQ/IQ/OQ package, the IQ/OQ package or solutions in accordance with customer requirements
  • qualification with Zwick: complete solutions from one source ensure greater cost-effectiveness
  • professionally generated qualification documentation in accordance with current guidelines
  • qualification on-site by experienced Zwick service technicians in the course of commissioning and calibration of the material testing system
  • utilization of wide-ranging Zwick expertise in medical engineering and the pharmaceutical industry
  • expert knowledge and advice pus long-term technical experience from a single source
  • Zwick is EN ISO/IES 17025 accredited; the relevant calibrations can be performed in the course of qualification.

Additional information can be found in our Product Information Qualification (DQ IQ OQ) for the Medical and Pharmaceutical Industries


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