iQue® 21 CFR Part 11 Software Module
Next Level iQue® Productivity for Regulated Laboratories
Designed for speed to actionable results, the iQue® is an instrument of choice for busy laboratories. With the ability to phenotype cells and quantify biomolecules like cytokines in the same experiment, iQue® allows for multiple experiments in the same well at the same time. Fixed optics and predesigned templates support reliable and reproducible data collection critical for regulated environments.
Building on the productivity of iQue®, the 21 CFR Part 11 Compliance-Enabling Module helps maintain electronic records with seamless, integrated global event tracking, electronic signatures and more. Whether you currently maintain electronic records or anticipate transitioning in the future, this module can support your needs. Features include automation compatibility, customized audit reports and filterable and searchable audit logs.
iQue® 21 CFR Part 11 Software Module Features
Security and User Control
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.
Electronic Signatures and Customization
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. Forecyt® with the 21 CFR Part 11 Compliance Enablement Module utilizes Windows Authentication to provide and maintain secure control over user IDs and passwords.
Electronic Record Keeping and Traceability
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, Forecyt® is designed to run as a closed system. Both the equipment and data can only be accessed through Forecyt® user interface by authorized users.