Customer use case: LIMS at a medical technology company
We can say a lot about ourselves and our software. However, no one can say more about our software than our customers, who use it every day.
Our user reports show how companies achieve success with our solutions. There is no better way to find out what our customers think! The following is a user report on LIMS at a medical technology company
LIMS Use Case
- Overview: International manufacturer of implants for joint replacement surgery uses CAQ software from Quality Domain to save more time in data acquisition in the future.
- Challenge: Compliance with standards and guidelines, as well as recording, managing and analyzing the enormous amount of data.
- Solution: Introduction of QMS goods receipt for immediate visibility and easier handling of data.
- Result: Reduction of errors and time savings in data collection
The challenge: data collection and traceability
The medical industry is under close scrutiny. Many checks have to be carried out and the authorities specify a range of standards and guidelines. Such as DIN EN ISO 13485 or FDA21 CFR Part 11, according to whose specifications the CAQ software must also work.
Furthermore, companies that manufacture medical products are legally obliged to store all their process data for 30 years so that even years later it is still possible to say exactly which patient has had which implant inserted. And how the part was manufactured or with what results. This means that a complete process history must be ensured for every product manufactured over the past 30 years.
Solution: QM incoming goods
The company first started a pilot project and implemented QMS in the incoming goods department. For the first time, the workers were able to carry out their inspections graphically and with text support. The inspection planning was set up identically to the production process. One advantage of computer-aided data recording is the ability to immediately visualize all recorded measurement data.
After successful completion of the pilot project, validation was carried out by the FDA. An external auditor inspected the entire process chain, from development and pilot series to market launch. After successfully completing the validation and realizing the versatility of the software, the customer decided to integrate further QMS modules into their production, such as the SPC software or the Import Manager with the Import Server.
Due to the simple handling of the software, only the training of a quality representative was necessary.
Result: Decades of availability of all data and significant time savings in data acquisition
Thanks to computer support, the customer is now able to display all process-related data for a part at any time. In addition, statistical evaluations can also be carried out retrospectively with just a few mouse clicks.
For certain product families, time savings of 20-30% have even been achieved in data acquisition and a reduction in the susceptibility to errors has been observed.
Thanks to the implementation of QM, the workers are now able to see directly in which area of the specification the currently measured value is located. Trends are therefore easily recognizable, so that an early reaction is possible before tolerance violations can even occur.
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Ludmila Lebedev
Sales Team Germanedge