Complete Peace of Mind
Fully automated 21CFR Part 11-compliant data logging with secure Cloud storage
Monitor your data 24/7 from any internet-enabled device
Live notifications sent to every member of your team
Each WiFi data logger connects automatically to the 21CFR Cloud and also stores readings internally in case the connection is interrupted
Cloud features include powerful data analysis, and user and location management, so the system scales easily
Perfect for compact systems with only a few loggers as well as large-scale solutions with hundreds of devices in locations worldwide
Entry-Level Data Logging
Easy to configure 21CFR Part 11-compliant USB data loggers with extra-long battery life
Set your own high and low alarm levels - LEDs flash when alarm levels are breached
Clear display that shows the latest, maximum and minimum readings
Each logger can store 200 days' worth of data
Free software to configure your logger, download your data, and graph and analyse the results
Why 21CFR Part 11?
21CFR is a set of regulations issued by the US Food and Drug Administration (FDA). Part 11 provides the criteria for the FDA to accept electronic records as equivalent to signed paper records with regard to data security. Even outside the USA, 21CFR Part 11 compliance is fast becoming the de facto global standard for electronic records management and control in the food and pharmaceutical industries.
21CFR compliance is required of US food, pharmaceutical and healthcare companies and any such companies outside the USA that want to operate in the USA.
EasyLog 21CFR-compliant data loggers include the following special features:
- User Control for Permission-Based Use - Ability to create users and assign individual users with specific permissions.
- Full Audit Trails - Full software and session data audit trails showing user activity.
- Electronic Signatures and Authority Sign-Off - Electronic signatures for all activity. This means the addition of electronic signatures to all reports to show who has started, stopped and approved the session data, and allows for authority sign-off.
- Encrypted Data Storage - Encrypted data which cannot be edited.
- Failed Log In Alerts - E-mail alerts for failed log in attempts.
- Comment Approval - Comments on specific readings must be approved by an authorised user for final submission.
Calibration Assures Accuracy
All EasyLog 21CFR data loggers can be provided with a calibration certificate
They are calibrated using apparatus traceable to national or international standards
Each logger purposefully tested at the temperatures you will be using it in