BioTrends EM® is an Environmental Monitoring platform for regulated microbiology laboratories. It provides structured control from activity planning to investigation and advanced trend analysis, contributing to the definition and implementation of the Contamination Control Strategy (CCS) required by Annex 1.

Designed according to GAMP 5 guidelines, BioTrends is aligned with Annex 11 requirements and integrates functionalities supporting Data Integrity principles, including verified audit trails, traceability, and secure access control.
The platform enables scalable management of high-volume monitoring programs and supports inspection readiness.

BioTrends EM® is developed by Archilex SA, a Switzerland-based software company with over 25 years of experience in regulated environments and more than 40 BioTrends installations worldwide.

Contatti

Aspetti organizzativi e Amministrativi
Antonio Izzo – antonio.izzo@archilex.com

Responsabile del Software Biotrends
Damiano Zin – damiano.zin@archilex.com