Gyrolab® software

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Gyrolab software is designed with GxP and 21 CFR Part 11 compliance in mind

Productivity at home, office, or lab.

Gyrolab xPand and Gyrolab xPlore™ instruments are delivered with an easy to use, pre-installed software suite providing the functionality to design, run, execute, and analyze automated microfluidic immunoassays.

  • Plan and set up runs in the lab or remote
  • Integrate and automate workflows with the Gyrolab Control module
  • Analyze data and generate reports with Gyrolab Evaluator
  • Meet 21 CFR Part 11 requirements, with straightforward assay development and transfer within regulated environments.
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Designed for optimum workflows

Gyrolab software is optimized for productivity in and out of the laboratory. Gyrolab Manager is used to plan and set up runs in the lab or remote, Gyrolab Control integrates and automates workflows, and Gyrolab Evaluator provides the power to analyze data and generate reports.

Gyrolab software is optimized for productivity in and out of the laboratory

Gyrolab software is designed with GxP and 21 CFR Part 11 compliance in mind

All software programs and modules are designed to meet 21 CFR Part 11 requirements, ensuring straightforward assay development and transfer within regulated environments.

Gyrolab software features in compliance with 21 CFR Part 11 include:

  • Audit trail to log all changes and modifications
  • User access levels and passwords with unique login ID and password
  • Defined Gyrolab user roles and software privileges
  • Administrator privileges to define custom-made user roles with unique privileges to control the level of user access
  • Electronic signatures to sign off after evaluation of results in Gyrolab Evaluator
  • Gyrolab Control Report with option to generate non-editable raw data reports after each run
  • Gyrolab Service organization support for Gyrolab systems in GxP environments
Gyrolab service and support

Gyrolab software modules provide expanded functionality

Gyrolab software modules add functionality onto the core software suite for additional application-specific analysis, and are designed with 21 CFR Part 11 compliance in mind.

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Gyrolab LIMS Interface

Software module to integrates Gyrolab system into a LIMS workflow.

Gyrolab Control Report

Enables automatic generation of 21 CFR Part 11 compliant, non-editable, raw data report after each run.

Gyrolab Viewer

Provides access to binding profiles of each data point directly from within Gyrolab Evaluator.

Gyrolab ADA Software

Enables analysis of anti-drug antibodies using Gyrolab CDs. Supports ADA assay workflow through development and validation to screening and confirmatory analysis.

Gyrolab Affinity Software

Enables Affinity software module from Gyrolab Evaluator.

Gyrolab Software Simulator Package

Laptop computer with a full installation of all Gyrolab software in a simulated instrument software environment. Include Gyrolab User Licenses (P0004955).

Gyrolab Software Validation Package

Documentation package with requirements and test specifications for Gyrolab Manager, Gyrolab Control, and Gyrolab Evaluator.

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Fully automated Gyrolab LIMS Interface

Biopharmaceutical companies and contract research or contract manufacturing organizations (CRO/CMO) companies often require a Laboratory Information Management System (LIMS) interface for sample tracking and data storage. Gyrolab software provides several options for a LIMS interface.

 

Worklist-mediated, manual Gyrolab run setup LIMS Interface

  • Information on samples to be processed during a Gyrolab run are provided to Gyrolab software by the LIMS
  • Gyrolab software returns Run Results back to the LIMS
  • User can automatically export Run Results with Gyrolab Result Exporter, maintaining data integrity in a secure process

Worklist-mediated, manual Gyrolab run setup LIMS Interface

Fully automated LIMS Interface

  • LIMS communicates directly with Gyrolab software via a network Application Programming Interface (API) to set up a Run, and to later fetch the Run Results
  • Gyrolab software returns Run Results back to the LIMS
  • Gyrolab network API available with Gyrolab Control 8.1 or later

Fully automated LIMS Interface

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gyrolab-control-report-run

Gyrolab Control Report

An essential requirement of 21 CFR Part 11 is the generation of non-editable, raw data reports after each run. Gyrolab Control Report module automatically generates non-editable raw data reports after each run, in alignment with 21 CFR Part 11 compliance.

For users who use a LIMS system for data analysis, this module delivers reports that include run and experimental details in pdf format.

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Gyrolab Viewer

Gyrolab Viewer enables visualization of the on-column fluorescence binding profile for each data point, revealing the binding interaction of each analyte with the column. The Gyrolab Viewer profile is a uniquely powerful tool for assay development and troubleshooting.

Gyrolab Viewer is accessed directly through Gyrolab Evaluator to facilitate assay development and troubleshooting from research through regulated environments. Binding profiles from Gyrolab Viewer can also assist in the selection of optimal binding pairs by comparison between data points.

Gyrolab Viewer

Gyrolab Viewer profiles facilitate assay development and QC data analysis

  • Compare binding profiles
  • Identify optimal binding pairs
  • Investigate outliers
  • Troubleshoot during development or routine analysis

Gyrolab Viewer profiles facilitate assay development and QC data analysis

 

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Assessment of anti-drug antibodies (ADAs) is a fundamental part of immunogenicity testing

Gyrolab ADA Software Module

Assessment of anti-drug antibodies (ADAs) is a fundamental part of immunogenicity testing. Gyrolab ADA Software follows a standard ADA assay workflow of screening followed by confirmatory assays to provide time-efficient, drug-tolerant analysis of anti-drug antibodies (ADA) in serum samples.

The Gyrolab ADA Software module incorporates a cut point formula for automatic data evaluation, displaying data according to predefined acceptance and cut point criteria for clear visualization of results.

Gyrolab ADA Software guides confirmatory analysis by displaying results according to your acceptance criteria and confirmatory cut point. Samples falling outside of acceptance criteria are automatically highlighted.

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Gyrolab Affinity Software

Gyrolab Affinity Software

Gyrolab Affinity Software module guides the design and evaluation of in-solution affinity experiments to determine KD values for up to 14 interacting pairs.

  • One interactant in a concentration series is mixed with the second interactant at a fixed concentration
  • At equilibrium, the response of unbound ‘fixed’ interactant is measured with an automated Gyrolab Affinity analysis method
  • The Affinity Evaluator Software generates affinity curves by plotting the response against the concentration of the variable interactant.
  • The affinity curves are fitted according to the selected interaction model.
  • Multiple curve analysis from one interaction pair is available with Gyrolab Evaluator v.3.6 and higher to obtain globally fitted parameters.
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Shorten software validation time with Gyrolab Software Validation and Simulator Package

Gyrolab Software Validation and Simulator Package

Shorten software validation time

Validating new software releases can be time consuming, taking up valuable instrument time to run validations. Gyrolab Software Validation and Simulator Packages provide tools for speeding up validation processes.

Gyrolab Software Simulator Package

Gyrolab Software Simulator Package consists of a PC with a full installation of all Gyrolab software in a simulated instrument software environment. The simulator PC can be used to evaluate new Gyrolab software releases and prepare for software validation without having to upgrade the Gyrolab system in the lab. The PC with the simulator installation may also be used for formal validation of Gyrolab Evaluator and Gyrolab Manager.

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Gyrolab Software Validation Package

Gyrolab Software Validation Package is a documentation package with requirements and test
specifications to facilitate validation of the Gyrolab software packages: Gyrolab Control, Gyrolab
Manager, and Gyrolab Evaluator.

 

Tools to speed up Gyrolab software validation:

  • Evaluate new Gyrolab software releases with Gyrolab Software Simulator Package
  • Prepare for software validation without having to upgrade the Gyrolab system PC
  • Carry out testing of Gyrolab software outside the lab without occupying the instrument
  • Create your validation plan using Gyrolab validation documentation with software requirements and test specification
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