Is LabVIEW CFR 21 Part 11 Compliant?

Updated Aug 6, 2018

Reported In

Software

  • LabVIEW

Issue Details

Is LabVIEW Software CFR 21 Part 11 compliant? How do I create applications with LabVIEW which are CFR 21 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)).

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

Using LabVIEW to Create FDA 21 CFR 11 Compliant Applications

Refer to the above White Paper to know how one can create CFR 21 Part 11 compliant applications using the LabVIEW Datalogging and Supervisory Control (DSC) module.

You can find such an example in the Related Links section.

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