Is LabVIEW CFR 21 Part 11 Compliant?

Updated May 13, 2019

Reported In

Software

  • LabVIEW
  • LabVIEW Datalogging and Supervisory Control Module

Issue Details

Is LabVIEW Development Software compliant with FDA regulations, such 21 CFR Part 11? How do I create applications with LabVIEW which are 21 CFR Part 11 compliant?

Solution

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

Application development software as such cannot be compliant to any regulation; it is rather the application created from the software that should be compliant.

Refer to Using LabVIEW to Create FDA 21 CFR 11 Compliant Applications for more information on creatting 21 CFR Part 11 compliant applications using the LabVIEW Datalogging and Supervisory Control (DSC) module. You can find an example of how to do this in the Related Links section.

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