agency
(21 CFR part 11 compliant)
application(s)
pharmaceutical
General description
M-Trace® Software allows automizing and digitalizing all data recording steps of sterility testing or any other quality control workflow for advanced data integrity and data traceability. Moreover, it improves process safety, allows obsolescence of paper-based documentation and improves data recording efficiency.To get started with M-Trace® Electronic Test Record Software, first digitalize the existing SOPs by creating fully customizable Master Test Records (MTRs) that will guide you through the workflow. During routine testing, register information on samples, consumables, test points or devices and conveniently assign test result to it, independently from location within your facility with M-Trace® Mobile App. The proper execution of a work step can be confirmed either by voice control or by machine-to-machine communication to allow real time documentation also when hands are busy with other operations for example inside an isolator. In parallel thanks to connection to the Steritest® Symbio pump, instrument parameters such as pump speed, pressure from instruments or a detailed pump activity profile are automatically registered as well. Comprehensive reports are then automatically created containing all information on consumables used, potential incidents that occurred and confirmation that each work step has been carried out properly as defined before in the MTR.
Features and Benefits
- Automatically record a complete set of data for each sterility testing that allows full traceability, e.g. to facilitate potential root cause analysis
- Full regulatory compliance by recording all data real-time
- 21 CFR p. 11 compliance
- Improved efficiency and time saving for your documentation, batch release and OOS investigation processesS
- upport to organize your sterility test, e.g. by automatically generating list of consumables needed
- Increased process safety: Be alerted upfront to avoid using wrong or expired consumables or to conduct wrong process step
- No more paper forms in your lab
- Connection to the Steritest® Symbio pump to allow machine-to-machine communication and semi-automated control of the pump
- Easily train new operators with detailed instructions in a closely monitored environment
- Preinstalled and prevalidated on M-Trace® All-in-One Computer for easy installation with options for advanced integration into your QC-IT environment such as connection to LIMS
Legal Information
M-TRACE is a registered trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany