Customer use case: LIMS at a medical technology company
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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.
Get in touch!
Would you like to know more about our solutions? Then please write me using the contact form. I will get back to you as soon as possible.
Ludmila Lebedev
Sales Team Germanedge
Seamless global integration of QMS into decentralized ERP infrastructure
Project overview
A global manufacturer of plastic products at over one hundred locations uses our QMS LIMS software to enable cross-location processing of inspection orders. Furthermore, the aim of the LIMS software is to create comparability between the plants through identical evaluations of the same materials or products.
The challenge
The QMS LIMS serves as a system for the laboratory for data acquisition and for quality management and development as a tool for evaluations. The central system is used for all locations of a business unit. The challenge here is to standardize the different processes and philosophies of the locations in one LIMS system. The connection of the decentralized ERP systems also poses a challenge. As part of the project, different IT systems and working methods had to be harmonized in one LIMS.
Solution
The QMS LIMS module is used in direct connection via our module for ERP integration with the decentralized ERP systems. Test planning is mainly carried out in the SAP QM module and the site-specific standards stored there are used. In some cases, several ERP systems communicate with a shared laboratory and its QMS LIMS database.
The QMS solution is used for complete order management, from receipt of the sample, sample preparation, pre-treatment and recording of measured values to the subsequent decision on use. Furthermore, the order planning is followed by an evaluation of the measured values collected in the form of test reports, forms and business intelligence reports.
The respective test devices and systems are addressed directly via the QMS LIMS using uni-respectively bidirectional interfaces and the results of the respective tests are read out using predefined rules. The customer uses various types of interfaces, from file import interfaces to web service interfaces.
It is crucial for the customer that all measuring devices are connected to the QMS LIMS in order to realize fully automatic data acquisition. By connecting the test equipment, the resources of the employees are spared, as they can focus entirely on the day-to-day business. It also optimizes the time required for order processing, as the effort involved in the inspection process is reduced. By connecting test equipment to QMS LIMS, the customer ensures that all tests are controlled by the laboratory and that tests can be compared at any time.
Its use is not limited to the basic function of a LIMS. At many sites, QMS is used to record data for incoming and outgoing goods inspections or for related analyses, such as mixture releases. In addition, QMS is used for the internal laboratory performance of test equipment capability analyses. Thanks to the high degree of configuration options, the data can be reused or reused for complete consistency within the customer’s application.
Result
The fully automated data acquisition leads to a more effective use of capacities in the laboratory. As a result, employees are able to focus on their day-to-day business. The fully integrated and digitalized process provides better transparency across the entire process, as all process steps are mapped via the LIMS. By concentrating on the day-to-day or core business, the throughput times for test orders have been reduced.
The digitalization of laboratory processes enables the customer to have a paperless laboratory. The central storage of all relevant data for a business unit enables global comparability of materials (finished products, raw materials, etc.).
A look into the future
The global roll-out is currently being implemented together with the Quality Domain project team. By reusing generic templates, resources are saved on the customer side and sibling sites can be connected within a few weeks.
Get in touch!
Would you like to know more about our solutions? Then please write me using the contact form. I will get back to you as soon as possible.
Ludmila Lebedev
Sales Team Germanedge