DATA SHEET TMI-Orion Qlever Software Food processing Pharmaceutical Medical Software solutions for TMI-Orion data loggers monitoring inside pharmaceutical, medical and food industries processes. Qlever is a software solution for the acquisition, analysis and visualization of data measured by TMI-Orion data loggers. Qlever helps define the conditions of use of TMI-Orion and customer equipment, collect raw data, calculate and create industry oriented measurement and validation reports. It offers ease of use, flexibility, and customization. TMI-Orion offers a wide range of industry oriented software modules which work in combination with Qlever software platform. A choice of Qlever Modules address the specific reporting needs of the pharmaceutical industry, laboratories, health centers, autoclave validation, medical device manufacturers, and the food processing industries. Qlever is a highly reliable software solution used with TMI-Orion data loggers, including FullRadio loggers which allow monitoring and process control of industrial processes. TMI-Orion Qlever

Qlever SOFTWARE PLATFORM Qlever is the general platform of our software offering. It operates alone or in combination with one or several industry specific software modules. • Qlever: Software platform dedicated to the management of one or several TMI-Orion data loggers. Set up and programming of TMI-Orion equipment, collection of data, processing (lethality calculations F0 / A0 / Vp, saturated steam, ...), analysis and display of data. • Qlever Lite: Simplified software solution intended for managing a single wired TMI-Orion data logger. Cannot be combined with any of the software modules. Only...

SOFTWARE MODULES TMI-Orion offers a range of industry oriented software modules which can be combined to answer the specific reporting requirements and needs of pharmaceutical industry, medical sector and food processing industries. These modules operate together with Qlever software platform. • Authentication-tracking Module – Compliant with FDA 21 CFR Part 11 Dedicated to secure management of user access, with creation of different accounts and access levels (Administrator, approval, operator). Complete tracking of processes and data including any addition, deletion or modification operation...

• Mapping module Intended for climatic and thermostatic chambers – or any kind of thermal regulation devices such as rooms, ovens, autoclaves - characterization and checking of temperature and humidity. Data treatment and presentation in an extensive compliance report with FDX 15-140 / IEC 60068.3.11. Example of graphic visualization • Calibration module Dedicated to TMI-Orion temperature and humidity loggers calibration process: calibration, adjustment, checking and editing of a report. Available with a library of drivers, to communicate with a wide variety of calibration equipment: baths, ovens,...

Solutions Qlever Pharmaceutical industry Medical sector Food processing industry Included in the Pharma module Software modules Qlever Lite* IQ/OQ protocol *Qlever Lite cannot be combined with software modules. IQ/OQ validation protocol: TMI-Orion offers an optional document including the installation qualification protocol and the operational qualification protocol of each Qlever software module. The validation protocols generally integrate in the customer quality

TECHNICAL SPECIFICATIONS • Intuitive interface and file management. TMI-Orion format data files. Raw data cannot be modified, and the entire database is highly secured by encryption. Import and export of data files. Database backup and restore. Minimum environment for the software: - RAM: 4 GB - Disk space: 200 MB (not including the data measured by the loggers) FDA 21CFR Part 11 compliant with an encrypted database, secure access, audit trail and data modification prevention. Compatible with Windows® Vista / 7 / 8 / 10. Search engine by key words. Multi-lingual environment. Mono or multi workstations...