Micro-EM is a risk based environmental monitoring solution manage sampling of controlled environments for viable air particulates as well as surface viables, allows for assessment of effectiveness of cleaning/disinfection. allows for identification of trends and facilitate early detection of potential problems. Micro-EM is FDA CFR 21 Part 11 complies, achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of regulations agencies. Micro-EM manages and automates EM data in a scheduled and workload manner to facilitate EM automation. Simultaneous qualification of process capabilities and Integral handling of deviations and related tasks.
The FDA believes manual systems of environmental monitoring (EM) have large inherent operational risks, therefore they are difficult to validate, if it isn't documented, it wasn't done and if it wasn't done using an appropriate process, it wasn't done properly. Computer trending for pattern recognition is the most efficient and effective way to handle such large quantities of data. Rick Friedman
Micro-EM is a newly configured solution developed to handle environmental monitoring of controlled pharmaceutical areas.
Achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of regulations agencies.
The quality of the laboratory work is only as good as the quality of the samples it uses for testing.
Micro-EM is a a major tool for operational management of laboratorie to ensuring smoother control processes.
From the sample registration to the final reporting, full laboratory management reporting system.
Micro-EM collect and manage effectively the test results which fall outside acceptance criteria .
Experience your data, any way, anywhere and view a complete picture of your informations in graphical manner.
Micro-EM provides for each registered user a dedicated profile includes user documents, tasks and requestitions.
The security administrator authority possesses the ability to manage roles and user security objects.