User Manual

General Enhancements
9
Siemens Desigo CC
Building Technologies What's New in Version 3.0
Support for validated environments
Characteristics
Desigo CC V3.0 provides Pharma and Life Sciences customers with the ability to
establish portions of their building automation system compliant to international
regulations, such as US FDA 21CFR Part 11, GMP Annex 11 or similar.
Elements:
• Validated Objects - Engineer/configure, operate and monitor certain
critical objects in a specific manner, compliant to the pharmaceutical
regulatory requirements. Users can be required to re-enter passwords or
enter comments before commanding or modifying a validated object.
• Audit Trail - Track the system and user activity of critical objects in an
operating and engineering audit-trail that is retained and protected from
tampering.
• Access Security – Restrict the ability of a set of users to make changes to
critical objects without either identity confirmation or additional
permissions.
• Reporting - The ability to retrieve data stored data in various graphical or
tabular report formats.
• Long-term Archiving of data – Provide a means to export recorded trend
and audit trail data while retaining data integrity and long term
accessibility.
Process:
• Record changes in conditions – Monitor and record variability in
temperature and humidity
• Track changes made to the system – Monitor and record changes made
to validated objects, such as set points, trends, ands schedules.
• Prevent unauthorized changes – Require proper authorization to change
settings of validated objects.
• Report recorded data – Output into industry standard graphs and tables
as required by internal and external audits
• Store and protect data – Keep years worth of recorded data safe,
protected from alteration, and accessible to users
Benefits • Reliable and safe environment, norms compliant
• All pharma features are provided with a single product
• No need to buy a dedicated system on top of the building management
Customer Value
Validation is made on the object level – it is not necessary to validate a complete
Desigo CC installation, only validate what is required. With validation in Desigo
CC, the customer can:
• Cover all building disciplines and sizes
• Record and track changes made to the system
• Prevent unauthorized changes
• Worldwide availability for multi-national enterprises