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SIMATIC HMI WinCC V7.0 System Description - DCE FEL ČVUT v ...

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3.5 Traceability and validation Options <strong>SIMATIC</strong> <strong>WinCC</strong><br />

Requirements and licensing<br />

● Microsoft Windows Server operating system at the location<br />

of the audit database<br />

● Audit complete package RC: license for runtime and<br />

configuration (engineering) on each operator station on<br />

which <strong>WinCC</strong>/ChangeControl is configured.<br />

● Audit runtime package RT: license for runtime on each<br />

operator station on which configuration changes are<br />

logged.<br />

Application<br />

Once a plant has been commissioning and validated, if<br />

necessary, the project version is archived via project<br />

versioning. Each time the configuration changes as the<br />

result of small adjustments, large expansions, or anything in<br />

between, all changes made in the plant are recorded seamlessly<br />

with <strong>WinCC</strong>/ChangeControl (in a change log), thus<br />

providing specific, documented evidenceof changes made,<br />

for example, when the plant is expanded. The change log<br />

covers the entire plant, from machine-level configurations all<br />

the way to higher-level <strong>WinCC</strong> projects.<br />

The reproducible versions of the <strong>WinCC</strong> project created with<br />

project versioning make it possible to go back to the last<br />

executable version or any other version in the event of<br />

problems with the plant or expansions.<br />

In the event of plant shutdowns, for example, plant constructors<br />

(such as OEMs) or plant operators can quickly and<br />

efficiently verify the changes that have been made in the<br />

plant and can infer the cause of the problem. This facilitates<br />

error analysis, saves services costs, and reduces downtime.<br />

You can also perform a risk analysis of the change based<br />

on the change log in the event of plant expansion and subsequent<br />

revalidation. <strong>WinCC</strong>/ChangeControl also helps you<br />

fulfill traceability requirements in compliance with<br />

FDA 21 CFR Part 11 and EU 178/2002.<br />

Configuration auditing<br />

In the course of a configuration, changes are made in various<br />

<strong>WinCC</strong> editors. These changes are logged with configuration<br />

auditing. Examples:<br />

● <strong>WinCC</strong> Explorer with central properties, such as clientserver<br />

● Tag management with communication links<br />

● Message system<br />

● Archive system<br />

● Text Library<br />

● User administration with access rights<br />

● Reporting and logging system<br />

● <strong>WinCC</strong>/User Archives<br />

Every change generates an audit trail entry, which is stored<br />

in the audit database. This audit trail contains the following<br />

information:<br />

● Time stamp<br />

● Modified object: old value, new value<br />

● User logged on to the <strong>WinCC</strong> server<br />

● Computer name of the <strong>WinCC</strong> server<br />

● <strong>WinCC</strong> project<br />

Some objects are not stored in the <strong>WinCC</strong> database and<br />

cannot therefore be logged in audit trails. These include<br />

process pictures and scripts you create yourself. Changes<br />

made to these objects are recorded by document control.<br />

Document control<br />

Figure 107 Archiving and restoring projects or project<br />

data<br />

In order to version individual local files in the <strong>WinCC</strong> project<br />

during configuration, place them in the document control<br />

database:<br />

● Process pictures<br />

● C functions and C actions<br />

● VBScript functions and VBScript actions<br />

● Line layouts and page layouts<br />

● Any documents in the project folder<br />

When a file is changed, a local copy of the file from the<br />

document control database is created. Other users are not<br />

able to edit the file during this time. After the change is<br />

made, the file is returned to the document control database<br />

as a new version, along with change information added by<br />

the user. This allows you to track individual changes from<br />

version to version, in the change history, for example, in<br />

which each change is clearly documented. If necessary,<br />

previous versions and deleted files can also be restored in<br />

<strong>WinCC</strong>.<br />

Special features<br />

● In the Audit Viewer, audit trails (configuration auditing)<br />

can be displayed, searched, filtered, printed, and exported<br />

as .xls files. Query Builder is used to create, save,<br />

and edit user-specific queries for audit databases.<br />

● In addition, all documents in the project folder under<br />

"Misc. Documents" are automatically added to document<br />

control.<br />

● You can compare the current version of a file with its<br />

previous version.<br />

● The document control database can be archived.<br />

<strong>SIMATIC</strong> <strong>WinCC</strong> <strong>System</strong> <strong>Description</strong><br />

70 A1900-L531-B996-X-7600, 09/2008

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