21 CFR Part 11 Workflows

21 CFR Part 11 Workflows in LabImage

The following list shows a typical workflow for a 21 CFR Part 11 compliant installation including the process to aquire image data from an external device.
Workflow Steps Description Screens and Image
Login into LabImage User name and passwort is used to login into LabImage. LabImage allows definition of:
  • Password Security (length, character settings, history)
  • User Roles/Groups
  • Definition of Work Groups
  • Each user access is logged
                
Create new analysis using imagers Imagers (e.g. Bio-5000 scanner) can be used to generate image within a closed system. Image data will never leave that system so data integrity is guaranteed.
  • external imagers can be integrated incl. calibration
  • predefined methodes are used to load image data with a single click
  • image meta data is stored in Audit Trail
Learn more about how to integrate Microtek Bio-5000 2 platform scanner using methodes,
 Analyze your data Data Analysis is supported by LabImage’s workflow based system. Each workflow can be customized to specific needs.
  • Custom workflow support fast and efficient data analysis
  • Each step is stored in an Audit Trail
  • Audit Trail provide search feature to seach for functions and full text
Approve data After completion projects can be approved. Approve depends on user rights.
  • Right to approve data depends on user group
  • analysis is stored as read only project
  • Audit Trail can be exported as PDF
 Summary LabImage provides a closed workflow to generate images, analyze and document data according to FDA 21 CFR Part 11.
  • image data will never leave the closed Part 11 system so data integrity is guaranteed
  • users work within a single software environment, no need to switch between different software
  • All actions are stored within a single Audit Trail – from image meta data to approve process
  • Stand-alone and network versions are available