iQue^® 21 CFR Part 11 Software Module

With the 21 CFR Part 11 Compliance Enablement Module, user roles can be secured to ensure everyone has the appropriate level of access. Only authorized individuals can control actions executed by the equipment through the software. Multiple permission levels are provided to ensure each authorized user is only able to perform their assigned tasks.

Control the level of electronic signature frequency. Create standardized log comments for organizational consistency. Username, date/time stamp and action performed are all stored in data files. The database and global audit log files can be exported to a pdf report. Electronic signatures are locked with the recorded action. Records cannot be falsified. iQue Forecyt^® with the 21 CFR Part 11 Compliance Enablement Module utilizes Windows Authentication to provide and maintain secure control over user IDs and passwords.

Software includes electronic record keeping of all user activities - from quality control (QC) to experiment design - through data analysis. Sequential layout wizards guide users to support compliance. In addition, customized education is provided for users to properly run the equipment and software. Only valid actions and data files are inputted into the system. The system also makes documentation available for system operation and maintenance. To ensure authenticity, integrity and confidentiality of electronic records, iQue Forecyt^® is designed to run as a closed system. Both the equipment and data can only be accessed through iQue Forecyt^® user interface by authorized users.