The iQue® software module for 21 CFR Part 11 ensures next-level iQue® productivity for regulated laboratories.
Designed for speed and actionable results, iQue® is the instrument of choice for busy laboratories. With the ability to phenotype cells and quantify biomolecules such as cytokines in the same experiment, iQue® allows for multiple experiments in the same well simultaneously.
The reproducible and reliable data collection essential for regulated environments is supported by fixed optics and predesigned templates.
The 21 CFR Part 11 Compliance-Enabling Module builds on the productivity of iQue® by helping to maintain electronic records with seamless, integrated global event tracking, electronic signatures, and more. This module supports the user’s needs, whether they currently maintain electronic records or expect to transition to them in the future.
Some included features are automation compatibility, filterable and searchable audit logs, and customized audit reports.
The iQue®️ 21 CFR Part 11 Software Module
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Users will benefit from the following:
- High-throughput screening: Rapidly receive actionable, compliant screening data from iQue® with Forecyt® software and the iQue® 21 CFR Part 11 Software Module. Click here to view flow cytometry instruments.
- Optimized application-specific reagent kits: 21 CFR Part 11 seamlessly works with iQue® applications such as antibody characterization, inflammation, cell health, phenotyping, and more. Click here to view flow cytometry reagents.
- Eliminating data analysis bottlenecks with Forecyt®: From plate creation and annotation to IC50 calculation, Forecyt® software finds hits while integrating traceability and security. Click here to view flow cytometry software.
Image Credit: Sartorius
Image Credit: Sartorius
Image Credit: Sartorius
iQue® 21 CFR Part 11 Software Module features
Security and user control
User roles can be secured using the 21 CFR Part 11 Compliance Enablement Module to ensure that all users have the appropriate level of access.
Actions executed by the equipment through the software can only be controlled by authorized individuals. Multiple permission levels are provided to ensure that every authorized user can only perform their assigned tasks.
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Customization and electronic signatures
The user can control the level of electronic signature frequency. For organizational consistency, standardized log comments can be created.
Data files are used to store usernames, date and time stamps, and actions performed, the database and global audit log files can be exported to a pdf report, and a recorded action is used to lock electronic signatures.
Moreover, records cannot be falsified. Forecyt®, with the 21 CFR Part 11 Compliance Enablement Module, utilizes Windows Authentication to offer and retain secure control over passwords and user IDs.
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Traceability and electronic record keeping
Electronic record-keeping of all user activities is included in the software, from quality control (QC) to experiment design through data analysis. Sequential layout wizards guide users to support compliance. Furthermore, customized education is provided that will allow users to run the software and equipment properly.
Only valid data files and actions are input into the system. Documentation is made available by the system for system maintenance and operation. Forecyt® is designed to run as a closed system to ensure the authenticity, integrity, and confidentiality of electronic records. Only authorized users can access the equipment and data through Forecyt® user interface.
Image Credit: Sartorius