The product
What does BioTrends EM do?
BioTrends EM® manages microbiological environmental monitoring from sampling plans to sampling, incubation, reading, review, reporting and trend analysis. It connects field and laboratory activities in one traceable system for pharmaceutical operations and other regulated GMP environments.
Which monitoring categories does it support?
Air, surfaces, water, compressed gases and personnel, together with microbiological controls on raw materials and finished products. Each category has dedicated fields and settings within a common planning and review framework.
How does BioTrends EM support trend analysis?
Interactive graphs show results over time against configured alert and action limits. Teams can compare sampling points, explore microorganism distributions and trace results back to their sampling sessions. Statistical tools also calculate suggested limits for review, without automatically changing the configured thresholds.
FIELD AND LABORATORY OPERATIONS
Can operators use BioTrends EM directly in the field?
Yes. BioTrends EM Mobile guides sampling, incubation and reading on supported Android PDAs with integrated 2D scanners. Barcode and DataMatrix scanning link samples to the relevant monitoring records. Supported devices include selected rugged healthcare and ATEX-rated models.
Can BioTrends EM Mobile work without Wi-Fi?
Yes. Operators can continue supported activities offline using data prepared on the PDA, then reconnect and initiate synchronization. Until synchronization, new records remain on the device and are not available in the central database. Functions requiring server access are available only online, and simultaneous work on the same points or plates across offline devices should be avoided.
How are results checked against limits?
Results are compared with the alert and action limits configured for the sampling point. Visual indicators and messages highlight excursions, helping operators identify results that require attention.
Is independent colony count verification mandatory?
The verification requirement is configurable. Where required, CFU counts must be checked by an operator other than the original reader. Settings can cover all results, positive results or zero results; verification can also be performed selectively or disabled according to the site's procedures.
Can BioTrends EM import instrument data?
Yes. BioTrends EM imports data from supported MAS-100 air samplers and microbial identification systems, including MALDI-TOF. Other instruments can be integrated through compatible CSV, XLS or similar exports, linking results to the corresponding sampling records.
Compliance and IT
How does BioTrends EM support GMP procedures?
BioTrends EM supports controlled workflows through user permissions, independent approval, electronic signatures and audit trails. These controls support the site's GMP procedures and data integrity requirements. The system must still be validated for its intended use, and regulatory responsibility remains with the site.
How does it support data integrity?
Sampling records connect results with the relevant points, materials, operators and activities. Electronic signatures control defined approval and closure steps, while audit trails preserve the history of changes. Changes to signed session data follow a controlled signature cancellation process, with specific provisions for subsequent microbial identification entries.
Where is BioTrends EM installed?
BioTrends EM Core resides on a Windows application server and can be launched from client PCs or accessed through Remote Desktop Services (RDS). It connects to a central Microsoft SQL Server database hosted on a physical or virtual company server. Multiple users can work concurrently, and the Multi Plants Module supports several plants or buildings within one installation.
Which languages are available?
Italian, English, French, German and Spanish. Support for additional languages can be evaluated on request.
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