The MadgeTech 4 Secure Software aids in compliance with 21 CFR Part 11 requirements. The 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.
IQ/OQ/PQ protocols are included with the purchase of the MadgeTech 4 Secure Software to validate that the software has been installed and is operating correctly.
The software is not compatible with all MadgeTech data loggers. The following data loggers are not compatible: