Qualification of materials testing machines and devices

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.

Legal Requirements and Responsibilities

Extremely high demands are placed on quality assurance in the medical and pharmaceutical industries.

National and international laws and directives such as the German Act on Medical Devices Act and the US Food and Drug Administration’s Code of Federal Regulations (CFR) require that all processes and computer-controlled systems directly related to product manufacture must be subject to validation. Observance of these guidelines is verified in an audit. This requires appropriate documentation and supervision of all activities.

The responsibility for validation lies with the regulated company.

It must establish guidelines and procedures for the validation which fulfill the legal requirements. Good Automated Manufacturing Practice (GAMP) serves here as a globally recognized code of practice for validation. It describes the tasks and duties 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.

The regulated undertaking must check whether the ZwickRoell testing systems used in the medical engineering and pharmaceutical industries are subject to the legal requirements so that qualification is necessary. The operator of the system is required to maintain the valid status of the system throughout its lifetime.

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ZwickRoell Supports Customers with DQ, IQ and OQ Qualification

ZwickRoell qualification services include

Consultation provided by experts
Design qualification (DQ): operational description with hardware and software components
Installation qualification (IQ) and operational qualification (OQ) of the testing system on site
Re-qualification of existing ZwickRoell materials testing machines and instruments

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.

Product information: Qualification of ZwickRoell testing system (DQ/IQ/OQ)

Flexible and Modular Qualification Services

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

Functions
Hardware
Software
Mechanics
Electrics
Electrical data and interfaces
Non-functional properties (for example, risk analysis)

Installation qualification (IQ)

Scope of delivery
Safety devices
Installation

Operational qualification (OQ)

Safety devices and power failure
Data storage
Function test
User management and user management guidelines
If the testXpert Expanded Traceability option is purchased Electronic data management (audit trail) and electronic signature

Additional ZwickRoell Benefits

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.

References

Many customers from the medical and pharmaceutical industries worldwide rely on ZwickRoell products and services.

We have successfully completed our qualification service on over 400 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.

Haselmeier relies on ZwickRoell's Materials Testing Laboratory for expertise in pharmaceutical pen testing.

Haselmeier is a leader in the development and manufacturing of innovative self injection devices. Numerous international pharmaceutical manufacturers are customers of this Swiss company. In addition to testing production batches of pen injectors, ZwickRoell's Materials Testing Laboratory offers DQ/IQ/OQ qualification and measurement system analysis of the testing system used for the tests.