Customer Use Case: LIMS at medical device companies

Medical Device

We ourselves can tell 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 use cases show how companies achieve success with our solutions. There is no better way than to hear what our customers think!

Below is a use case about LIMS topic.

  • OVERVIEW: International manufacturer of implants for joint replacement surgery uses QM software from QDA SOLUTIONS to save more time in data collection in the future.
  • CHALLENGE: Compliance with standards and guidelines, as well as the collection, management and evaluation of the enormous amount of data.
  • SOLUTION: Implement QDA SOLUTIONS’s QDA Incoming Inspection for instant visibility and easier handling of data.
  • RESULT: Reduction of errors and time savings in data collection.

CHALLENGE | Data Collection Traceability

The medical industry is under close scrutiny. Many inspections must be performed and the authorities specify a number of standards and guidelines, such as DIN EN ISO 13485 or FDA21 CFR Part 11, according to which CAQ software must also work.

Furthermore, companies that manufacture medical products are legally obligated to store all their process data for 30 years, so that even years later it is possible to say exactly which patient has received which implant, 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 | QDA Incoming Inspection

The company first started a pilot project and implemented QDA in the incoming inspection department. For the first time, the workers were able to carry out their inspections graphically and text-supported. The inspection planning was set up identically to the production process. One advantage of computer-aided data collection is the possibility of immediate visualization of all recorded measurement data in control charts or value progression charts.

After successful completion of the pilot project, validation by FDA was carried out. From the development, through the pilot series, to the market launch, an external auditor took a look at the complete process chain. After successful completion of the validation and the realization of the versatile application possibilities of the software, also in other areas of production, the customer decided to integrate further modules of QDA into their production, such as SPC Software, Calibration Management software or the Import Manager with the Import Server.

Due to the ease of use of the software, only the training of a quality representative of the company by QDA SOLUTIONS was necessary.

RESULT | Decades of availability of all data as well as significant time savings in data collection

Thanks to computer support, the customer is now able to view all process-related data at any time. In addition, statistical evaluations can also be carried out retrospectively with just a few mouse clicks.

For certain product families, a time saving of 20-30% could even be achieved during data collection and a reduction in the number of errors could be determined.
Through the implementation of QDA, the workers are now able to directly see in which range of 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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Profilimage of Tomasz Lacheta

Tomasz Lacheta