In many cases, the FDA does require the validation of commercial software for its intended use. The FDA
has stated, “The agency believes that commercial availability is no guarantee that software has undergone
‘‘thorough validation’’ and is unaware of any regulatory entity that has jurisdiction over general purpose
software producers.
The agency notes that, in general, commercial software packages are accompanied not by statements of
suitability or compliance with established standards, but rather by disclaimers as to their fitness for use. The
agency is aware of the complex and sometimes controversial issues in validating commercial software. However,
the need to validate such software is not diminished by the fact that it was not written by those who will use
the software.”1
The FDA requests that your Learning Management System is validated for intended use.
Compliance with GxP predicate rules (e.g. 21 CFR 210 or 21 CFR 820) in combination with electronic records as
per 21 CFR Part 11 or EU GMP Annex 11 for computerized systems is mandatory in regulated environments.
