Tài thiệu thẩm định thiết bị

1. Product Information
Qualification of Zwick testing systems (DQ/ IQ/ OQ)
Zwick
Materials Testing
PI7622.0415
Legal requirements
Quality assurance in the medical and pharmaceutical
industries is subject to highly exacting demands.
National and international laws and directives such as the
German Medicine Act (MPG) and the US Food and Drug
Authority’s Code of Federal Regulations (CFR) require that
all processes and computer-controlled systems directly
related to product manufacture must undergo validation.
Observance of these guidelines is verified in an audit.
This in turn necessitates appropriate documentation and
supervision of all activities.
The responsibility for validation lies with the
regulated undertaking,
which must establish guidelines and procedures in order
to comply with the legal requirements.
Good Automated Manufacturing Practice (GAMP) serves
as a globally recognized code of practice for validation.
It describes the roles and responsibilities of the supplier
and the end user, together with the validation process.
A significant element of validation is the technical
inspection of individual systems and devices. This section
is designated Qualification.
Qualification process
• planning phase, leading to performance
specifications
• definition of technical specifications, with verification
in Design Qualification DQ
• Risk Analysis RA
• correct supply and installation of the system, which
forms the basis of the Installation Qualification IQ
following commissioning
• check for successful calibration
• check for correct basic operation during
Operational Qualification OQ
• check reproducibility of specified processes or
parameters in Performance Qualification PQ
The regulated undertaking must check whether the
Zwick testing systems used in the medical engineering
and pharmaceutical industries are covered by the legal
requirements, making qualification necessary.
The end user (system owner) of the system is required to
maintain valid system status throughout its lifetime.
We reserve the right to make technical changes in the course of ongoing development.
Schematic of validation process
Zwick provides support
in the qualification of materials testing systems during the
DQ, IQ and OQ steps, in the form of comprehensive and,
on request, individually tailored qualification documenta-
tion, as well as in the practical on-site implementation of
qualification.

2. Product Information
Qualification of Zwick testing systems (DQ/ IQ/ OQ)
Zwick
Materials Testing
PI7622.0415
Advantages of qualification by Zwick
Cost and time savings
No need to tie up capacity in the preparation and
implementation of qualification.
Standardized document structure enables rapid project
implementation.
Expert advice
Zwick has the necessary expert knowledge to provide
competent advice on the required scope of qualification.
Guarantee of success
Qualification is performed on-site at your premises by a
specialist in the hardware and software used in the Zwick
testing system.
The individual test items are carried out and each
successful IQ or OQ test is signed by the qualifier and end
user. The results of IQ and OQ are summarized in the IQ
and OQ Reports.
Know-how
Trained service technicians carry out qualification on-site
in the course of commissioning and calibration.
Quality
Zwick hardware and software is designed for the regula-
ted environment. Zwick is EN ISO/IEC 17025 accredited
and can provide a ‚one-stop‘ service of qualification plus
calibration of testing systems.
The choice is yours
Zwick services are available on a modular basis. 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.
We reserve the right to make technical changes in the course of ongoing development.
Benefit from our wealth of experience
The content of the documents is based on years of
experience in the qualification of testing machines. The
documents are continually updated to conform with new
rules and knowledge.
All documents are checked and approved by Zwick and
must be authorized by the customer before qualification
is carried out.
Flexibility
Customized expansion of the standard Zwick documen-
tation is possible whenever required.
The standard documentation covers the following tests:
Relationship of qualification documents

3. Product Information
Qualification of Zwick testing systems (DQ/ IQ/ OQ)
Zwick
Materials Testing
Qualification by Zwick - overview of availability of qualification services
Basic requirement
A key requirement for qualification of a Zwick testing
system is testXpert II testing software.
We do not currently provide a qualification service for
testXpert Research and Dynamics.
Qualifiable testing systems
Zwick provides a qualification service for all static testing
machines which are equipped with either standard electro-
nics, testControl or testControl II. The qualification portfolio
also includes electro-mechanical testing actuators with
testControl electronics.
For Zwick testing instruments such as hardness testers,
extrusion plastometers, pendulum impact testers etc.
we are looking into the possibility of qualification on ap-
plication.
testXpert II - Expanded Traceability option
From testXpert II V3.4 onwards the ‚Expanded Traceability‘
option has the necessary requirements to satisfy all criteria
of FDA 21 CFR Part 11.
* not part of the product portfolio
We reserve the right to make technical changes in the course of ongoing development.
PI7622.0415