QX ONE Software, Regulatory Edition #12012078



QX ONE System Control and Analysis Software, with traceability for secure environments  



Use QX ONE Software Regulatory Edition, to assist in compliance with U.S. FDA 21 CFR Part 11 regulations when performing PCR experiments on the QX ONE System.

QX ONE Software Regulatory Edition works in conjunction with the built-in security features of the Microsoft Windows 10 operating system to provide a security environment for the maintenance, verification, and tracking of all electronic records generated by the software. When properly configured and administered, these tools ensure compliance with the rules for secure handling of electronic records as outlined in Title 21, Part 11 of the Code of Federal Regulations (CFR).

Key Features

  • Streamlined workflow system control and analysis
  • Easy Plate Set up with multiple descriptor fields for sample names, well notes, and plate notes
  • Supports simple to advance analysis for all experiment types and plex modes experiment
  • Customizable data handling and report generation

Key Security Features

  • Mandatory password-protected log-in — log-in required; administrator sets user privileges
  • Time- and date-stamped audit trails — edit information is tracked and saved. Audit trail records reason for save and option to export as PDF report
  • Lot management tool — document consumable and reagents lot information
  • Electronic signatures — multiple electronic signatures can be applied at any editing step
  • Download the instruction manual to learn more about QX ONE Software Regulatory Edition and the QX ONE Digital PCR System

Product Contents

  • QX ONE Software Regulatory Edition
  • USB license key

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