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SIMATIC WinCC flexible 2007 together with the options WinCC
flexible/Audit ,WinCC flexible/ChangeControl and SIMATIC Logon offers everything you
need to simplify the validation of machines and plants.
- All changes to the system are logged in detail, whether it is in
Runtime mode (Audit trails) or in configuration (change logs).
- All relevant data which are stored electronically are protected
against unauthorized changes
WinCC flexible thus provides a most
convincing and comprehensive answer to the requirements in these
industries- especially for applications close to the machine based on
Panels and Multi Panels (Series 270
devices and
higher). Audit makes it easier to construct machines for these
branches of industry, since the important functions to meet these
requirements are already offered as-standard, which means that it is
possible in this way to qualify individual machines or standalone plant
sections at the suppliers‘
WinCC flexible Options for FDA Validation
WinCC flexible/Audit -
Recording of operator inputs in Audit Trails
In operation, the system records all relevant changes to tags and any
operator actions in accordance with Good Manufacturing Practice (GMP) as
Audit Trails and saves them to a CSV file.
You can provide additional prompts for an electronic signature and a
commentary in the case of operator actions.
It is possible to visualize in a userfriendly way the Audit Trails that are
registered in the project using a
Viewer. Tracking changes in manufacturing processes by means of Audit
Trails is possible from 270 Series Panels onwards.
further information about WinCC flexible/Audit
WinCC/flexible/ChangeControl –
Versioning and change tracking of projects
Once a plant has been commissioned and validated, it may be necessary to
make changes to the configuration due to the plant being adapted or extended.
Using the WinCC flexible/ChangeControl option, you can record all the changes
to a plant from the start of production for the entire service life and, with
software in particular, you can document reproducible versions and even carry
out a rollback.
further information about WinCC flexible/ChangeControl
SIMATIC Logon
Central, plant-wide user management
The user administration with the SIMATIC Logon option integrates into
the security system and user management of Windows and thus meets the
FDA requirements. SIMATIC Logon comprises a number of security
maechanisms and provides a plantwide user management
further information about
SIMATIC Logon
PM-OPEN IMPORT
When running WinCC flexible in combination with a central WinCC
system, PM-OPEN IMPORT offers the possibility to import the WinCC
flexible archives(data logs, alarm logs and audit trails) automatically
into the WinCC system. Thus these data can be archived for a long time
period in a SQL Server database format while WinCC flexible uses CSV
files for archiving.
further information about PM-OPEN IMPORT
Compliance Response 21CFR Part11
In order to support a validation process we offer a whitepaper,
which contains detailed answers to the FDA requirements for
a machine monitoring based on WinCC flexible.
Download of whitepaper:
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FDA-Compliance
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Good Manufacturing Practice
Pre sales info