Schneider Electric Building Automation Systems and FDA Compliance

[Product_Support]

Issue

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

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

• Vista
  21CFRPart11 support in TAC Vista 5.pdf
  FL-VISTA-REGIND-A4 mod RO.pdf

• I/NET - currently unavailable

• Andover Continuum
  With the addition of the 21 CFR Part 11 compliance pack, Continuum can meets these requirements.

• Satchwell Sigma
  SoftwareOverview.pdf
  Advanced Security Module.pdf

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