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 testing systems used in the medical and pharmaceutical industry, because these systems are subject to various legal requirements or regulations (for example, under Ordinance on/Decree for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV), EU GMP Guideline, or 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.
Extremely high demands are placed on quality assurance in the medical and pharmaceutical industries. National and international laws and directives 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 results in a need for appropriate documentation and supervision of all activities in order to minimize risks and guarantee patient safety.
The responsibility for validation lies with the regulated undertaking: The regulated undertaking (operator) must establish guidelines and procedures to satisfy the legal requirements. Good Automated Manufacturing Practice (GAMP) can be applied 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.
- ZwickRoell qualification documents are brought together in a basic package covering the basic equipment of the testing system.
- Since 2015 regulated undertakings have been required to produce User Requirements Specifications (URS) (EU GMP Annex 15). We therefore provide support in the form of a specification document specifically tailored to our testing systems. This can assist you in the creation of your URS.
- The individual specifications are transferred to the Risk Analysis (RA) and assessed there for relevance to GMP and occupational health and safety. All specifications classified as relevant to GMP and occupational health and safety are channeled into the Design and Test documents and are reviewed during Qualification.
- Traceability is ensured throughout, from the specification of the testing system to the RA to the Design and Test documents.
- Generation of test system specification (as of testXpert III)
- Generation of Risk Analysis (RA) based on testing system specification. The RA serves as a traceability matrix
- Review of the design defined in the specification of the testing system within the Design Specification (DS)
- Verification of correct delivery, installation, and documentation of the system within the scope of Installation Qualification (IQ)
- Verification that the testing machine and software can perform their basic operations correctly during Operational Qualification (OQ)
DQ Design Qualification
- Specification of the testing system
- Design Specification (DS) including FDS/ HDS/ SDS
Installation Qualification (IQ)
- Scope of delivery
- Safety devices
Operational Qualification (OQ)
- Safety devices and power failure
- Data storage and function tests
- User Management
- If part of the order: Traceability and electronic signature
In addition to the basic package, ZwickRoell can also provide semi-individual/individual and periodic qualification.
In the case of semi-individual qualification the basic documentation can be expanded to include your additional requirements. Individual qualification can be based on either the basic documentation or your User Requirements Specification (URS).
The basic package includes comprehensive documentation consisting of the testing system specification, an RA, DS, IQ, and OQ. All documents will be made available to you for review and authorization before qualification takes place.
Qualification will be performed on-site at your premises by specially trained ZwickRoell service technicians.
Cost and time savings
- No tying-up of your resources in preparing and implementing qualification.
- The bottom-up document structure enables rapid project implementation.
- The content of the documents is based on years of experience in the qualification of testing systems.
- The documents are continually updated to conform with new rules and new insights derived from the market.
- ZwickRoell has already performed over 1,000 successful qualifications–both nationally and internationally.
- Experienced, specially trained service technicians carry out the qualification step by step following commissioning and calibration at your premises.
- Qualification of a ZwickRoell testing system which has already been installed is also possible.
- ZwickRoell possesses the expertise required to provide competent advice on the required scope of the qualification.
- The scope of the qualification can be expanded on the basis of the basic documentation.
- We will also be happy to produce a completely individually tailored qualification based on your User Requirements Specifications (URS).
- ZwickRoell is ISO/IEC 17025 accredited and can provide calibration of testing systems in addition to qualification services, all from a single source.