The FDA requires Building Automation systems to meet their standards which are outlined in Chapter 21 CFR and FDA Part 11.
TAC I/NET, TAC Vista, Andover Continuum, Satchwell Sigma, TAC I/A Series
- Andover Continuum
- TAC I/A-series
- Satchwell Sigma
Finding documentation on Schneider Electric Building Automation Systems which comply to The Food and Drug Administration rules.
- I/NET - currently unavailable
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