CiTect for Pharm Application, was 21 CFR Part 11 for HMI's


Thread Starter


Has anybody any experience with CiTect in a pharma application? This appears to a be a weakness of the system, not having a track record.

Is the system 21CFR p11 compliant???
If I am correct then Tracing is a way of storing information about where a product has been going within a proces and have the means to analyse this way.
Tracing can been writen in Citect or can be coupled to a database (SQL) by easy software tools made by citect (PLANTtoSQL).
Also is Tracing a MES/MIS based information (a lot of databased information) there are very good programmes to do this job with Citect and are probably compliant with you application needs.
Citect is SCADA and is like all other SCADA applications not a databased MES/MIS solution. Citect gives very good ways to make the connection to MES/MIS and ERP.

Please contact your local Citect dealer of support office to get a good solution for your application needs.

Good luck, Sisko Bos

[email protected]

Greg Critton

If you aren't stuck on CiTect you might take a look at Rockwell Softwares' RSView32. They have some white sheets on using it for Pharm CFR and some succesful installations.

Greg Critton
Warren Electric Group
Automation Specialist (AB)

Walker Petroff

CIMScan is an alternative to CiTect and is 21CFR p11 compliant with audit trail and digital signatures in existing pharm applications. E-mail me at "[email protected]" if you'd like more information.

Kevin Altomare, CA

Anybody that tells you that a SCADA/HMI product is FDA compliant or 21CFR Pt 11 compliant is full of it. Installed systems need to be audited and then they are considered "FDA Validated". FDA validation is based on implemented systems because even top-notch software can be installed badly.

I know Citect have several FDA validated sites including AeroJet (here in California). Contact your closest Ci Technologies office and I'm sure they can help you out.