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Aiding in 21 CFR Part 11 Compliance

The MadgeTech 4 Secure data logger software aids customers in 21 CFR Part 11 compliance. These requirements are set out by the FDA, the Federal Food & Drug Administration of the USA which regulate the electronic records and the solutions that provide these records, such as data loggers.

Madgetech are a core provider of data logger applications and software that aim to accurately monitor, analyse and report on time and temperature, humidity and more.  The software ensures standards are upheld when taking electronic records as opposed to paper records, saving time and effort.  The data logger software contains criteria such as electronic signatures, access codes, secure data file, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity. Other features include:

  • User Management

Users can be given two levels of access to restrict others if needed. Users can control the data loggers and analyse their data, and administrators can do so as well as monitor security settings.

  • Audit Trails

The software keeps a record of all those who log in and out of the software, what files have been download and what data was used.

  • Electronic Signatures

Users and admin can add electronic signatures. The software will record the printed name of the signer, date and time of the signing and its meaning.

The layout of the secure software is similar to the MadgeTech 4 Standard Software, allowing users to easily learn the additional features. Graphs and data grids can now be linked so that users can easily modify views, and templates can be created to allow quick copies of settings which can be applied to data loggers of the same type to save time.

Data sets can now be dragged and dropped into a data grid to easily map out data and spot trends or conduct comparisons. Data can be copied and pasted from the software for easy transferal from the software to excel, emails and more.

Users can perform in-depth analysis of both individual and multiple datasets using the new math channels and statistics. This allows data to be automatically plotted onto a graph to create sophisticated reports which can be saved and printed for review.

IQ/OQ/PQ protocols are included with the purchase of the MadgeTech 4 Secure Software to validate that it has been installed and is operating correctly. Onsite support is available for IQ/OQ/PQ implementation and software training.

Contact Wessex Power for the latest version of the Madgetech 4 secure software with the protocol included to demonstrate your 21 CFR Part 11 compliance. Call +44 (0)1929 459 459 or view our brochure for more information.

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