Can Vijeo Designer v6.2 and a Magelis HMI be configured to be compliant with FDA Title 21 CFR Part 11 regulations for Electronic Records and Signatures?
Issue
Can Vijeo Designer v6.2 and a Magelis HMI be configured to be compliant with FDA Title 21 CFR Part 11 regulations for Electronic Records and Signatures?
Product Line
Vijeo Designer v6.2, Intelligent Data Services (IDS)
Resolution
Yes, Vijeo Designer v6.2 with Magelis HMI can be configured to be compliant with FDA Title 21 CFR Part 11 regulations for Electronic Records and Electronic Signatures.
The add-on component of Intelligent Data Services (IDS) running on a Windows PC must be used in conjunction with Vijeo Designer to meet the compliance.
Please see the attached document for details.
Intelligent Data Services can be used to write archive data to Microsoft SQL database as well as generate reports in Microsoft Excel, PDF, CSV and more file formats triggered by process events.
The Part Numbers for IDS v6.2 components are as follows:
IDS Manager: VJDSNTRCKV62M
IDS Report Printing: VJDSNTRPRV62M
Can Vijeo Designer v6.2 and a Magelis HMI be configured to be compliant with FDA Title 21 CFR Part 11 regulations for Electronic Records and Signatures?
Product Line
Vijeo Designer v6.2, Intelligent Data Services (IDS)
Resolution
Yes, Vijeo Designer v6.2 with Magelis HMI can be configured to be compliant with FDA Title 21 CFR Part 11 regulations for Electronic Records and Electronic Signatures.
The add-on component of Intelligent Data Services (IDS) running on a Windows PC must be used in conjunction with Vijeo Designer to meet the compliance.
Please see the attached document for details.
Intelligent Data Services can be used to write archive data to Microsoft SQL database as well as generate reports in Microsoft Excel, PDF, CSV and more file formats triggered by process events.
The Part Numbers for IDS v6.2 components are as follows:
IDS Manager: VJDSNTRCKV62M
IDS Report Printing: VJDSNTRPRV62M
Released for: Schneider Electric USA




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