Test equipment management with PRIMAS validated at a medical device manufacturer
The KLS Martin Group was looking for a test equipment management solution that would meet the requirements of the medical technology manufacturer's GMP and ISO 13485-regulated environment. Testo Industrial Services proposed their PRIMAS validated IT solution.
The KLS Martin Group is the umbrella brand for the Karl Leibinger Medizintechnik, Gebrüder Martin, KLS Martin and Rudolf Buck group of companies, as well as for numerous subsidiaries and representative offices around the world. The company manufactures a wide range of medical products - from surgical laser systems, implants for the mouth, jaw and face to sterilisation containers.
KLS Martin wanted a test equipment management system tailored to its requirements. The holistic solution needed to cover the entire process - from calibration, through logistics, to test equipmentmanagement in a validated IT system.
In addition, KLS Martin wanted to centrally manage approx. 4,500 test equipment across its three locations in a GMP-compliant test equipment management system. This enables the medical device manufacturer to meet the requirements in a GMP and ISO 13485-regulated environment.
Outsourcing the test equipment management process to Testo Industrial Services ensures that KLS Martin can fully concentrate on its core competence, the manufacture of medical devices. We have already completed the planning and implementation of the measures in the initial project phase in close coordination with KLS Martin. In addition, the company benefits from efficient processes and is secure in the knowledge that in the event of an audit, they are protected, especially regarding data integrity and data security.
„We wanted a partner who could support us in all of the processes related to the calibration of our test equipment. From the introduction of PRIMAS validated and during the validation of the system, regular meetings were held with the experts from Testo Industrial Services. Through some configuration options, the IT system could be easily adapted to meet our requirements. The entire validation project was straightforward and ended with the handover of the documentation. The team from Testo Industrial Services was able to understand our needs and implemented our requirements perfectly.“Ingo Preiser
Quality Assurance Manager
KLS Martin Group, Mühlheim
Your advantage: Our competence
- Introduction of a holistic test equipment management system incl. project planning: computer-aided management of test equipment, calibration, collection and delivery service.
- Mapping the company structure and its locations in PRIMAS validated
- Individual user authorisation concept for access to calibration & test equipment data
- Extensive protection measures to ensure data integrity & data security
- Initial validation and maintenance of validated status according to GMP requirements throughout the entire system life cycle of PRIMAS validated
- Process optimisation & central contact for test equipment management and order processing at Testo Industrial Services
Learn even more about this success story and take a look at the reference brochure.
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