THE SYSTEM
Precise monitoring for the highest demands
The vali.mon captures values from particle counters, environmental sensors and other devices in real time.
This data is collected, evaluated, compared with limit values and archived using customer-specific software applications.
Whether in cleanrooms, warehouses, or technical rooms – the system is versatile and fully tailored to your needs. Each system is unique.
WHY VALI.MON
Your advantages -
Our promise
Validated data, intuitive operation and full regulatory compliance – all in one system.
01
Validate
All data is verified and traceable information for which documented evidence exists that it is accurately, consistently, and in accordance with 21 CFR Part 11 and GAMP 5.
04
Quality & Safety
Our software ensures reliable collection and management of validated data in accordance with 21 CFR Part 11 and GAMP 5 – the highest compliance and security standards in regulated environments.
02
Adaptability
The system is completely flexible and is individually tailored to your requirements. Whether additional sensors, interfaces, or extended reporting – we adapt everything to your processes.
05
Intuitive Operation
Clear displays and intuitive menu navigation make vali.mon particularly user-friendly. Your data can be easily accessed at any time – without any technical expertise.
03
Custom Alarms
Threshold limits are customized to your specific products and requirements. If a threshold is exceeded, you will receive immediate alerts via
email, phone call, text message, or visual notification.
06
Flexibility
Depending on customer requirements, data can be recorded, displayed, and further processed in various ways. Interfaces such as OPC UA or SQL enable integration with external systems.
SYSTEM ARCHITECTURE
This is how it works
Your monitoring
Sensors
Temperature, humidity, pressure, particle counter and other signals
vali.mon Software
Real-time monitoring, analysis and alarm management
Control Cabinet
Analog and digital signals are collected and processed.
Alert
SMS, email and visual alerts when limit values are exceeded
Server
Centralized data processing with redundant storage
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Archiving
Long-term data storage, firewall protection, remote access
REAL-TIME DATA
Real Time Report -
All data at a glance
All relevant data from your processes can be viewed in real time. Critical parameters such as temperature, humidity, or particle count are monitored and displayed live.
Thanks to the real-time report, you can act proactively, minimize risks, and ensure the quality of your processes at all times.
SECURITY
Alarm Report -
Maximum safety
React quickly when needed. Our notification system alerts you immediately, in your preferred way, as soon as predefined limits are exceeded.
All alarms are fully documented – including timestamps, acknowledgments and comment functions for seamless tracking during GMP audits.
IN DETAIL
What we have for you
realize
21 CFR Part 11
Full compliance with FDA requirements for electronic records and electronic signatures.
EU GMP Annex 1
Monitoring systems for the classification and monitoring of cleanrooms in accordance with EU GMP Annex 1 – the relevant guideline for the manufacture of sterile medicinal products.
GAMP 5
Development and validation according to the industry-standard GAMP-5 framework for computerized systems in the pharmaceutical industry.
ISO 9001:2015
All processes of vali.sys ag are certified according to the international quality management standard and are continuously optimized.
HEADQUARTERS SWITZERLAND
ACCESSIBILITY
VALI.SYS EGYPT
CERTIFICATES & LINKS
vali.sys ag
Rosengartenstrasse 17b
8608 Bubikon
Switzerland
+41 43 495 92 50
Mon–Thu: 08:00–12:00 / 13:00–17:00
Friday: 08:00–12:00 / 13:00–15:30