What BioTrends EM is
BioTrends EM® manages the full microbiological environmental monitoring program of a regulated GMP site, from sampling plan to trend analysis. It guides operators on rugged Android PDAs during field activities, follows samples through incubation and reading, and keeps results, electronic signatures, reports and trends in one traceable, paperless record.
Developed and owned by Archilex SA in Switzerland, BioTrends EM® supports pharmaceutical operations and other regulated GMP environments.
Desktop
is the control center for microbiological Environmental Monitoring. It brings together sites, cleanrooms, sampling points, limits, sampling plans, schedules, electronic signatures, audit trail, reports and trend analysis, so the full program can be managed and reviewed in one traceable system.
Android PDA
supports operators directly in the cleanroom, guiding sampling, incubation and plate reading on a handheld device. Each plate is identified by barcode or Data Matrix scan, with work performed online or offline and synchronised automatically when the connection is restored.
What it monitors
The Workflow
On the floor
BioTrends EM® combines a Windows-based Core application with Android mobile workflows and a central SQL Server database.
Operators capture data at the point of activity. Laboratory teams manage incubation and results.
Authorized reviewers access the records needed to evaluate, sign and report the work.
Online and offline operating modes support different connectivity conditions.
Corporate authentication options include LDAP and LDAPS, with support for multiple LDAP hosts.
BioTrends EM Mobile runs on a rugged Android PDA with a 2D scanner.
Corporate directory
LDAP · LDAPS
Sign-in on PDA and Core
Android PDA
Operators capture data at the point of activity
SQL Server
One central database
Core · Windows
Laboratory teams manage incubation and results
Reviewers evaluate, sign and report
The PDA syncs with the database continuously.Records stay on the PDA until the operator syncs.
BioTrends EM Mobile
Sign-in
Store credentials on an NFC tag or bracelet to fill in the login fields. The interface is available in Italian, English, French, German and Spanish.
Sampling
Scan barcodes and DataMatrix codes to identify points, rooms, plates, media, devices, containers and personnel. Environmental, personnel and water sampling start from the same menu.
Incubation
Take plates in charge individually or in closed transfer containers. Changes to incubation hours and temperatures are recorded in the audit trail.
Reading
Record colony counts against the sampled point. Results that exceed the configured alert and action limits are flagged during data entry.
Verification and synchronization
Where enabled, a second operator verifies the count on the PDA. In online mode the device is synchronized regularly. In offline mode the operator reconnects and starts the synchronization.
Compliance support
An inspection comes down to questions about who did what, and when. In BioTrends EM the answers are already part of the record.
01 / 04
A second user — never the one who wrote it — with an electronic signature and an effective date. Until then the plan cannot generate a single session.
02 / 04
The operator who read it, and a different operator who counted it again. The system enforces the difference; it does not simply expect it.
03 / 04
Changes are recorded in the audit trail with who made them and when, listed by event type — result changes, incubation hours and temperatures, media replaced.
04 / 04
No. Reports are generated from signed sessions in PDF and XPS; they can be filed and classified, but not modified.
Developed to support FDA 21 CFR Part 11. It supports your compliant procedures and data integrity; it does not replace your validation or your regulatory responsibility.
Talk to our specialistsThe platform
BioTrends EM® combines a Windows-based Core application, Android mobile workflows and a central Microsoft SQL Server database, connecting field activities with laboratory operations and quality review.
Manage site structure, sampling plans, schedules, results and quality review from a central application. Deploy the system on a physical or virtual company server, with access from multiple client PCs.
Guide operators through sampling, incubation and reading on supported Android PDAs with integrated 2D scanners. Continue supported activities offline, then reconnect and initiate synchronization with the central database.
Integrate user authentication with LDAP or LDAPS, including support for multiple LDAP hosts. Configured roles and permissions control access to functions and authorized activities.
Import 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 BioTrends sampling records.
The shift
BioTrends EM® reduces manual transcription and brings monitoring records together, making laboratory work easier to review and trace.
Who it's for
Follow guided activities on the PDA, from sampling and incubation to colony counting, with data captured where the work happens.
Coordinate monitoring activities, review results and investigate trends across sampling points, areas and production batches.
Review monitoring evidence, apply electronic signatures and access traceable records to support quality oversight and inspection readiness.
Discover how BioTrends EM can support your monitoring activities, laboratory workflows and quality review.
