Validation Services - DQ, IQ and OQ Qualification Services

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.

DQ IQ OQ

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 Zwick 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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DQ, IQ and OQ Qualification Services Offer Outstanding Support

Our experts work closely with you whenplanning qualification services. Together we identify the technical and design specifications of yourprocesses and provide you with customized written documentation. Zwick then manufactures and installs yourtesting system in compliance with the specifications outlined in the designqualification phase. Finally, we checkthe operation of the system against a series of test cases to best representusage profiles. The test items andcorresponding acceptance criteria are defined and specified with you inadvance. 

  • Design qualification (DQ): Definition of technical specifications with verification
  • Installation qualification (IQ): Verification of correct installation of the system
  • Operational qualification (OQ): Verification of correct system operation
IQ OQ Qualifizierung

Substantial Value and Support for Regulatory Compliance

  • Saved time and resources:  Zwick prepares and implements the process for you.  
  • Increased accuracy:  An on-site Zwick specialist completes the qualification process as part of commissioning and calibration.  
  • Flexibility:  Zwick services are available on a modular basis.  You can choose between full qualification, partial qualification, or an individual package solution to suit your requirements. 

Additional Zwick 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 Zwick 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

Zwick 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 Zwick and must be approvedby the customer before qualification is carried out.

Proven quality

Zwick has been successfully auditedby several renowned pharmaceutical companies.

Zwick is EN ISO/IEC 17025 accredited and can provide calibration of testing systems in addition to qualification on a "one-stop" basis.

References

You can place your confidence in us to deliver exceptional support in the delivery of validation services. 

We have successfully completed our qualification service on over 400 Zwick 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.

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