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.


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High-throughput Screening

Obtain actionable, compliant screening data fast from your iQue® with Forecyt® software and the iQue® 21 CFR Part 11 Software Module

Flow Cytometry Instruments
ForeCyt Software

Eliminating Data Analysis Bottlenecks with Forecyt®

From plate creation and annotation to IC50 calculation, Forecyt® software finds hits while integrating security and traceability

Flow Cytometry Software
flow cytometry reagents

Optimized Application Specific Reagent Kits

21 CFR Part 11 seamlessly works with iQue® applications like antibody characterization, cell health, inflammation, phenotyping and more

Flow Cytometry Reagents

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.

Related Resources

21 CFR Part 11 Compliance Support Technical Specifications

iQue® Audit Trail, Electronic Records and Electronic Signature Features to Support 21 CFR Part 11 Workflows

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Powerful data analysis and visualization tools

Eliminating data analysis bottlenecks with iQue Forecyt® Software

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Forecyt® Enterprise 

Seamlessly sync iQue® data from multiple instruments safely and seamlessly across a network

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iQue® Reagent Kits 

High-Throughput, Multiplexed Solutions for Faster Time to Actionable Answers

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High-Throughput, Multiplexed Solutions for Faster Time to Actionable Answers

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