MadgeTech 4 Secure Validation Software Package
IQ/OQ/PQ secure software validation workbook and software package
The MadgeTech 4 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 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, 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. On-site 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.
• Install, validate and operate one software program universally
• Compatible with most MadgeTech products
• Time and cost saving validation package, stands up to interrogation from auditors
• Automatic data security and audit trail
• Sophisticated user maintenance
• Traceability with customizable electronic signatures and audit trails
• Aids in compliance with FDA 21 CFR Part 11/820 and GxP guidelines
• Pharmaceutical
• Medical
• Hospitals
• FDA regulated organizations
• Temperature Mapping
