Even outside the USA where it originated, 21CFR part 11 compliance is fast becoming the de facto standard for electronic records management and control in the food and pharmaceutical industries.
Combining two platforms for compliance – stand-alone USB and WiFi-based remote data loggers - with secure configuration and data collection software, FilesThruTheAir delivers all of the flexibility of an electronic monitoring system but with the controls that enable lock-down of data, a complete audit trail of system use and permission-based access to data and devices.
To see how our range of 21CFR data logging solutions will help you achieve compliance with 21CFR Part 11, download our requirements checklist.
21CFR Cloud-Based Data Logging
Need a remote 21CFR system? Try our range of WIFI-based 21CFR sensors for enhanced data security in a remote package.
Including all the benefits of our standard Cloud data logging services, 21CFR Cloud offers extra functionality required to meet 21CFR Part 11.
- Individual users can be assigned specific permissions
- Data is permanently stored and cannot be edited
- All activities are visible with a full audit trail
- Electronic signatures are added to all reports showing who has started, stopped and approved the session data.
21CFR USB Data Logging
As well as the core offering of the existing EasyLog software, individual users can now be assigned specific permissions while data stored in an encrypted format cannot be edited. The software provides a full audit trail of activities, with users being able to add comments to specific readings before being approved by an authorised user. Electronic signatures are added to all of the reports to show who has started, stopped and approved the session data.