21 CFR Part 11 Workflows

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

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,   

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

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

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