Our client came to us with a USB Data Logger that was configurable via a USB port and ensures digital security CFR 21 part 11 compliance, storing data in an encrypted format to obscure the tampering of data.
In collaboration with Lascar Electronics we completed a software package based on their design to allow a user/organisation to setup permissions for whom can setup, start and download encrypted data. A full audit trail is made available through software interaction and audit information available stored on the USB device itself.
A .net Windows application was created with the following features:
- Configure 21CFR data logger
- Download data in an encrypted format.
- View and analyse data via secure graphing application (fully auditable).
- Set user permissions for interacting with a USB Data Logger and secure data files.
- Ability to view and export an audit of all interactions via the software.
- Email a known administrator where there is potential for suspicious activity such as multiple failed login attempts.
The configuration application allows users to set a data logger’s parameters (how frequent to take a reading, alarm thresholds etc). Functionality is restricted based on permissions and data can be shared but stored in a format that cannot be tampered with or falsified.
With this suite of applications and the logger itself a customer can integrate data logging into their current CFR 21 process with ease.
“BioMedical has provided us with another great piece of software to complement our EasyLog hardware.
The team is able to interpret and evolve our requirements, to deliver solutions that exceed our initial expectations.”