Biotrends Em

BioTrends EM® is a software system developed for managing microbiological data of the environmental monitoring programs, thinked for pharmaceutical companies and improved year by year in tight cooperation with them. The software is in compliance with FDA 21 CFR part 11 & EU GMP Annex11. The program has evolved over time becoming a management system for the entire microbiological monitoring process, from planning and execution of sampling to incubation, to finish with plate reading and UFCs identification. The system also works in association with mobile devices with barcode readers that support operators and/or analysts, speeding up and facilitating all the aforementioned operations. The system provides a wide possibility of creating reports and trends that represents its native function, also other interesting features such as mapping the monitored areas to highlight any “hot spots” and the management of the qualifications activities. With an effective and simple to use sampling planner, the scheduling of daily / weekly / monthly activities can be assigned to single operators and programmed in advance. During data entry, the system will signal possible discrepancies and it will indicate when the acceptance levels are exceeded, keeping track of each operation in the audit trail. Thanks to the management of electronic signatures on records, BioTrends can be used to manage environmental monitoring without using paper.