MES Software complies with FDA 21 CFR 11 standard.
Press Release Summary:
MES Simatic IT Historian v6.0 supports audit trail and electronic signature and provides client/server service, which ensures data integrity. Electronic signature can be configured according to specific requirements and associated to any audit trail action. Software imports models from Simatic IT Production Modeler, generating KPIs associated with production-oriented events. Long-Term Archive function allows both on-line and off-line archiving.
Original Press Release:
MES-Software with Major Step Towards Full FDA-Compliance
New release 6.0 of MES-(Manufacturing Execution Systems)-Software Simatic IT Historian from Siemens Automation and Drives (A&D) covers major parts of FDA (Food and Drug Administration) quality standard 21 CFR Part 11. This standard is quickly becoming a legal stipulation worldwide for production plants in the pharmaceutical, food and drink and fine-chemicals industries.
Following FDA 21 CFR 11, in Version 6.0, Simatic IT Historian supports audit trail and electronic signature and provides a client/server service, which ensures data integrity even in case of communication failure. It also provides an interface to remotely manage these two features. The electronic signature can be configured according to the specific requirements and can be associated to any audit trail action.
Version 6.0 has also strengthened the integration with the plant model. In particular, Simatic IT Historian can import the models from Simatic IT Production Modeler, generating the KPIs (Key Performance Indicator) associated with production-oriented
events and the model from Simatic Batch retrieving data from Batch and process control system Simatic PCS 7 as well as from process visualization system Simatic WinCC and allowing EBR (Electronic Batch Recording) and reporting. In particular, the integration between Simatic WinCC and Simatic IT Plant Performance Analyzer is so tight that the latter can be used as an Option Pack for Simatic WinCC.
The new software also features the Long-Term Archive function, which allows both on-line and off-line archiving and permits to export off-line archives to durable media through export packages which include also all configuration information and possible audit trail / electronic signature requests associated with those archives.
Further information can be found on the Internet at: simatic-it.com
