The MadgeTech Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech Secure 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. Onsite support is available for IQ/OQ/PQ implementation and software training.
The layout of the secure software is similar to the MadgeTech 4 Standard Software, allowing users to easily learn the additional features.