ZwickRoell/DQ of IQ/OQ test system
In medical engineering and the pharmaceutical industry is a very important validation process for a specific plant and equipment technical review.ZwickRoell test system for medical engineering and pharmaceutical industry are required to do this kind of appraisal, because these systems are restricted by various regulatory requirements (for example, according to the drug laws and the active pharmaceutical ingredient production (AMWHV), the European Union GMP guide or the FDA 21 CFR part 11 of the regulations).
By providing comprehensive appraisal guidance document, or have a need to separate identification of guidance documents, ZwickRoell can support your material test system of DQ (design verification), IQ (installation identification) and OQ (identification) operation, and can also be used to your lab on-site verification service for you.
Legal requirements and guidelines
Medical and pharmaceutical industry particularly high demand for quality assurance.All national and international legal requirements related to production process and computer control system must be validated.Comply with the implementation of the guidance by the validated audit.Therefore, all activities need to be properly documented and supervision, in order to to minimize risk and ensure patient safety.
The responsibility of the validation is regulated enterprises:The regulated enterprises (operators) must be made in accordance with the law requires the guidelines and procedures.Production automation management specification (GAMP) is a global recognized test specification.It describes the task and responsibility of the suppliers and end users, and the validation process.Verification is an important element of individual systems and equipment for technical inspection, was found for this sectionIdentification of.
Provide identification service for new and existing test system
- ZwickRoell identification document is attached in the basic service package, which covers the basic equipment test system.
- Since 2015, the regulated enterprises are required to prepare the user requirements specification (URS) (eu GMP appendix 15).Therefore, we provide support in the form of a specification document, the document is customized specifically for our test system.This can help you create the URS.
- Various specifications have been transferred to the risk analysis (RA), and there are with GMP and the correlation of occupational health and safety assessment.Classified according to GMP and occupational health and safety of all specifications are included in the design and test documents, and during the appraisal review.
- From experimental system specification to risk analysis, to design and test documentation, traceability is guaranteed.
ZwickRoell appraisal process
- Generate test system specification (using testXpert III)
- Based on the test system specification to generate risk analysis (RA).Based on the RA can be traced back
- Within the scope of the design code (DS), defined in the specification review test system design
- Within the scope of the installation identification (IQ), verify that the system is correct delivery, installation, and archiving
- During the period of operation identification (OQ), and software validation testing machine can correctly perform the basic operations
Modular identification solution
In addition to basic service pack, ZwickRoell can also provide individual/personal and identification on a regular basis.
Under the condition of half personal identification, can extend the basic file to include your additional requirements.Personal identification can be based on the basic file or user requirements specification (URS).
Basic service package including the experimental system specification, RA, DS, IQ and OQ of comprehensive files.Before identification, ZwickRoell will provide you with all the documents for review and authorization.
Appraisal by professionally trained ZwickRoell maintenance technicians in the field.
We have successfully in more than 1000 ZwickRoell completed on material testing machine and instrument identification service.
Many customers from medical engineering and pharmaceutical industry all over the world rely on ZwickRoell products and services.
Be benefit from our appraisal services company, using our flexible and modular solution package.
