iQue® 21 CFR Part 11 Software Module

Top Features of iQue® 21 CFR Part 11 Software Module 

  • Audit Trail, Electronic Records and Electronic Signature Features to Support 21 CFR Part 11 Workflows
  • Custom standardized acceptance criteria for organizational consistency
  • Operator only user role   

Popular Applications for iQue® 21 CFR Part 11 Software Module 

  • Data traceability and accountability
  • Providing detailed record keeping submissions to agencies such as FDA, EMA
  • Tracking experiment design through to quality control

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*Custom/bulk order quotes are provided within 24 hours of request.

Secure Valuable and Important Data Derived from Precious Samples 

The 21 CFR Part 11 software module for iQue® lets you replace monotonous manual record keeping with an intuitive and secure electronic record keeping system.

Designed With Regulated Environments in Mind

Specifically designed to meet the increasing requirements for regulated laboratories. Secure user roles to ensure everyone has the appropriate level of access. Electronic record keeping of all user activities from experiment design through to QC, through data analysis are included. Control the level of electronic signature frequency. Create standardized log comments for organizational consistency and ease of use. Customized audit reports can display all records or be filtered by time frames, users or experiments.


  • Device/Instrument Compatibility

Product Information

  • Brand
  • System License
  • User License