Software
Software solutions for maximum safety and efficiency
With our intelligent software solutions from MK Versuchsanlagen, you can digitally and sustainably optimize your cleanroom processes – from precise glove testing to complete traceability and comprehensive data analysis. Our systems are modular, user-friendly, and fully compliant with GAMP 5, EU Annex 11, and 21 CFR Part 11. They integrate seamlessly into your existing IT infrastructure and provide maximum process security.
Automated Glove Testing – Precise, safe, efficient
The Glove Integrity Testing Software (GITS®) from MK Versuchsanlagen is your comprehensive solution for automated glove testing. The software allows simultaneous control and measurement of all connected testing devices – including individual parameters for each port, glove, or machine. Recipe assignments ensure a consistent testing strategy, while the machine validation view visualizes the status of all test points in real time.
Thanks to optional RFID-based port and glove identification as well as the auto-start function, validation can be carried out almost fully automatically. Each measurement is precisely assigned and documented, minimizing human error. GITS® is available in Essential, Professional, and Enterprise editions and can be fully integrated into SCADA/MES systems as well as your corporate network.
Complete traceability of the glove lifecycle
The Glove Life Cycle System (GLCS®) from MK Versuchsanlagen enables full traceability and monitoring of every glove used. The software automatically documents storage, sterilization, age, and cleaning cycles using RFID technology. This ensures the condition of each glove can be tracked, allowing for safe and compliant use.
GLCS issues warnings when defined limits are exceeded or automatically blocks tests if a glove no longer meets process standards. This prevents failures and allows early identification of critical glove positions – ensuring maximum safety and transparency throughout the entire lifecycle.
Centralized data analysis and reporting at a glance
The Analysis & Reporting Tool (ART) is your central platform for generating and evaluating all relevant data from GITS® and GLCS®. It supports the creation of machine reports, port reports, audit trails, and freely configurable evaluations – all within one centralized, network-enabled system.
With its comprehensive data base, trends can be identified, critical weak points analyzed, and well-informed decisions made. ART is highly customizable and delivers reliable reports in compliance with 21 CFR Part 11 – either electronically or as automated printouts.
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