To help customers comply with 21 CFR Part 11 requirements, MadgeTech has developed the MadgeTech 4 Secure Software Validation Package. 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 helps provide data integrity IQ/OQ/PQ protocols can be purchased and implemented to validate that the software has been installed and is operating correctly. Additional support is available for full software training. The layout of the secure software is similar to the MadgeTech Standard Software version, allowing users to easily learn the additional features. The software is not compatible with all MadgeTech data loggers.
On-site validation services available from Wessex Power delivering turnkey installation, validation and completion of IQOQPQ documentation.