FDA requirements applied to information systems are defined in the Code of Federal Regulation (CFR), chapter 21, part 11. Data management has to comply with rules intended to ensure data sustainability, authenticity, integrity and traceability.
EasyCDM Suite provides a fully featured, 21 CFR part 11 compliant EDC solution, giving both investigators and monitors a powerful yet easy-to-use environment for data entry and monitoring. EasyCDM Suite supports all the steps of the clinical trial process from translation of the clinical trial protocol to the consolidation of all collected trial data, ready for reporting and analysis. It is available online and can be securely accessed from anywhere by authorized users.