Schneider Electric Building Automation Systems and FDA Compliance

Issue

The FDA requires Building Automation systems to meet their standards which are outlined in Chapter 21 CFR and FDA Part 11.

Product Line

TAC I/NET, TAC Vista, Andover Continuum, Satchwell Sigma, TAC I/A Series

Environment

  • Vista
  • I/NET
  • Andover Continuum
  • TAC I/A-series
  • Satchwell Sigma

Cause

Finding documentation on Schneider Electric Building Automation Systems which comply to The Food and Drug Administration rules.

Resolution

  • I/NET - currently unavailable
  • Andover Continuum
    With the addition of the 21 CFR Part 11 compliance pack, Continuum can meets these requirements.

Note: Validation to 21CFR Part 11 can only be performed on whole operational systems and as such, a sub-system comprising the Satchwell Sigma building management system cannot be validated in it own right. Satchwell Sigma would normally be validated as part of a whole operational system.

  • TAC I/A Series - currently unavailable