Tinytag DI is the secure data logging software designed for aiding compliance with data integrity regulations in temperature and humidity monitoring applications.
Maintain compliance with MHRA Data Integrity and FDA 21 CFR Part 11
Tinytag DI’s range of data security features enables pharmaceutical companies and service providers to implement the required technical procedures to run a closed data logging system that is compliant to data integrity regulations, including MHRA (UK) and FDA (US) requirements.
Using Tinytag DI, pharmaceutical companies and logistics providers can securely monitor the conditions that affect the safety and integrity of pharmaceutical products during their manufacture, storage and transportation. Organisations can also prove their due compliance with data integrity regulations, both to auditors and clients.
Closed system: Robust protection against data manipulation
Tinytag DI protects pharmaceutical data from manipulation by ‘locking’ data loggers to a given system. Once added to a Tinytag DI system, a data logger can only be accessed by authorised users and it cannot be accessed on other data logging systems.
User access controls: Secure your data logging system
Tinytag DI’s user authorisation and authentication feature verifies authorised users each time they access the software. This protects your pharmaceutical data loggers from unauthorised access and ensures that activity in the data logging system is attributable to individuals.
With three user access levels – Operator, Power User and Administrator – organisations can apply appropriate levels of access to the system to individual users, ensuring controlled access to system functionality.
Access groups: Manage distribution of data loggers
With access groups, access to data loggers can be assigned to individual users, or it can be managed in groups according to organisational or structural needs. Users cannot view or interact with data loggers that are not assigned to them.
Audit log: Prove data integrity compliance
Tinytag DI’s audit log records user activity within the data logging system, including changes made to a data logger’s configuration and data downloads, as well as system events, such as alarm alerts and email warnings. All events in the audit log are displayed alongside the date, time, user, PC and data logger associated with the event, enabling a full reconstruction of activity within the data logging system.
Compatible with all Tinytag temperature and humidity data loggers
The Tinytag range of temperature and relative humidity data loggers provides versatile options for secure monitoring of pharmaceutical manufacturing, quality control, storage and cold chain distribution. Features include USB, Radio and LAN (Ethernet) connectivity, display screens, high- and low-temperature probes, thermocouples, waterproof (IP68) and splash-proof (IP65) casing and fast data offload.
Tinytag DI offers a straightforward user-experience, with data available to view in graphs, tables of readings and as summary information. Other features include data overlays and synchronisations, calibration reminders and data export via copy-and-paste or popular file formats (.xlsx, .xml, .txt. and .csv).
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