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 ZwickRoell 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).
ZwickRoell 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.
ZwickRoell qualification services include
The modular qualification documentation is customized by ZwickRoell to conform to the configuration of your ZwickRoell testing system.
All documents are additionally checked and approved by ZwickRoell and must be authorized by the system operator before qualification is carried out.
Experienced, specially trained service technicians carry out the qualification step by step at your site using the qualification documents.
You can choose between full qualification consisting of DQ, IQ and OQ, part qualification consisting of IQ and OQ or an individual package solution to suit your requirements.
Customized expansion of the standard ZwickRoell documentation is possible whenever required. The standard documentation covers the following:
DQ design qualification
Installation qualification (IQ)
Operational qualification (OQ)
Save time and reduce costs
You reduce the amount of resources you need to prepare and implement qualification.
Standardized document layout makes project implementation fast.
Success guarantee
Qualification is performed on site at your premises by a specialist trained in the hardware and software of the ZwickRoell testing system.
The individual test items are carried out and each successful IQ or OQ test is signed by the qualification specialist and end user.
The results of the IQ and OQ are summarized in the IQ and OQ report.
Consultation services provided by experts
ZwickRoell has the necessary expertise to provide competent advice on the required scope of qualification.
Specially trained service technicians carry out the qualification on site as part of commissioning and calibration.
Our qualification experts also provide comprehensive support for a qualification performed at a later point in time.
A wealth of experience
The organization and content of the documents is based on years of experience in the qualification of testing machines.
The documents are created in accordance with current guidelines and are continuously updated to reflect new rules and knowledge.
All documents are checked and approved by ZwickRoell and must be approvedby the customer before qualification is carried out.
Proven quality
ZwickRoell has been successfully auditedby several renowned pharmaceutical companies.
ZwickRoell is EN ISO/IEC 17025 accredited and can provide calibration of testing systems in addition to qualification on a "one-stop" basis.
Many customers from the medical and pharmaceutical industries worldwide rely on ZwickRoell products and services.
We have successfully completed our qualification service on over 750 ZwickRoell materials testing machines and instruments.
Join the group of companies who have benefited from our qualification services and take advantage of flexible and modular package solutions.
