Is Tinytag DI compliant with data integrity regulations?

Tinytag DI has a variety of features that enable Tinytag data loggers to become part of a closed data logging system that complies with MHRA GxP Data Integrity, FDA 21 CFR Part 11 and BS EN 12830 regulations.

Compliance with data integrity regulations requires a collection of both technical and procedural controls to protect data within a system. Tinytag DI software aids organisations with fulfilling the requirements of data integrity regulations by providing a thorough range of system controls for maintaining a closed data logging system that ensures the integrity of data.

Tinytag DI's range of practical security features include:

  • Audit log: ensure system activity is traceable and attributable

  • Data ID: data is traceable with unique ID generated upon download

  • User authorisation and authentication: restrict unauthorised access to closed system

  • User access levels: control user access to software functionality

  • Access groups: manage user access to data loggers

  • Lock data loggers to your system: prevent users from accessing data loggers on a different data logging system

For the medical, pharmaceutical and food industries, Tinytag DI software can help organisations to maintain data integrity compliance in line with regulations including MHRA Data Integrity, FDA 21 CFR Part 11 and BS EN 12830. [A Validation Pack for Tinytag DI is available to purchase separately for organisations who are required to independently validate the software in line with regulatory recommendations.]

Gemini Data Loggers also offers a calibration service for Tinytag data loggers that is traceable to national standards, helping users of Tinytag DI to validate the accuracy of the data loggers in their system.

For expert advice on how Tinytag DI could aid data integrity in your monitoring application, please get in touch with us on +44 (0)1243 813000 or at [email protected].