The process monitoring system maXYmos TL ML from Kistler has just received a new update. Version 1.8 further simplifies user management and increases measuring accuracy. Originally launched in 202, maXYmos TL ML is a system specifically designed for medical device manufacturers and plant builders for effective process monitoring, compliant with FDA and MDR regulations. The update also brings in additional features such as a new sensitivity correction functionality, an improved audit trial function and a master administration system.
Key highlights:
- FDA & MDR compliant
- Especially suited for medtech and pharma, but now also open for other industries
- Revised audit trail functionality
- Updated master login feature
- New sensitivity correction feature
With strict regulations and high requirements for product safety, quality management and process validation in the medtech sector, maXYmos meets the need for a process monitoring system that is compliant with FDA and MDR regulations. Used worldwide to improve the production quality of medical devices during joining and assembly processes and in testing procedures, the new features are sure to increase the number of users, as well as improve the effectiveness of the software for existing users. The new updates, such as the new sensitivity correction functionality, the improved audit trail function and a master administration system render it useful for industries other than the medtech sector as well. Any sector that depends on precise measurements, reproducible processes and traceability can benefit from the system.
Audit trail
Although the new update opens up the software for other industries, it specifically shines for the medtech and pharma sectors. It allows for measurements at low ranges and able to deliver 100-percent-testing during production, which is a critical requirement for manufacturers of medical devices, as this can eliminate the need for mandatory process validation. This is especially efficient, as the maXYmos TL ML system is integrated directly into the production line.
Another key feature is the direct batch release, which allows users to quickly switch between different batches with no additional quality assessment and validation. The function is based on a library of evaluation objects (EOs), a set of predefined tolerance boxes for good parts. The system gives the user the option to pre-qualify a set of EOs for each type of part that can be selected when batches change.
As end-to-end traceability is a regulatory requirement in medtech, the latest version of the system features a revised audit trail functionality. Via this function, the system monitors and records all changes to the testing device, including the indexing of time and user. This provides a standard solution in accordance with FDA and MDR regulatory demands and facilitates the mandatory archiving of the log files, as data can either be exported, for example to PDF files, or printed. Mostly, this audit trail functionality update reduces time spent on audit-related efforts.
With the new audit trail update comes a search and filter function for the logged files. The search function can show the history of the logs, such as who changed an entry, what was changed, when it was changed and also why it was changed. This data is saved directly on the device and so can be accessed easily by operators. For increased security, access is restricted to users with admin rights, which also comes with a newly improved system login: one master administration system means that the laborious task of logins for each separate machine at a plant can be avoided.
Sensitivity correction
The new sensitivity correction that comes with the 1.8 update is especially useful for in-line process monitoring of medical device manufacturing. This process normally presents multiple challenges, as measurements can deviate from realistically applied forces, due to the way sensors are mounted in the machine, or interferences resulting from adjacent cables. This can eventually lead to an offset between indicated values and the actual forces. The sensitivity correction of the system compensates these biasing factors, allowing users to define up to 31 support points on a non-linear curve that represent the swing of a real force. After measuring, they can be compared to the results from the force sensors and based on these insights, the force ranges can then be fine-tuned to match the measurement chain to its environment in an optimal way.