WinCC/Audit is for tracking adjustments in operator sports in runtime operation in addition to for recording project adjustments at the engineering stage. The gadget information all of the trade facts in a cozy database called the Audit trail. you can view the Audit path the usage of the Audit Viewer.
because of this the usage of WinCC/Audit affords non-stop traceability of both operator activities and modifications to projects and, on the same time, additionally allows system tool builders and plant operators to reduce the amount of engineering time and effort worried in complying with the necessities of 21 CFR element eleven and EU 178/2002. The engineering measures which can be necessary for making validation easier are documented in a white paper.
Reliable recording of operator actions and mission changesin Audit Trails
Challenge versioning and file manage
Compliant with the necessities of the FDA (food and Drug management)
Decreased engineering attempt to comply with 21 CFR component 11 &EU 178/200
Monitoring Runtime Operation
In runtime operation the machine data the following within the audit trail
Operating sports achieved,
Activities in the scope of valuable person management the usage of SIMATIC Logon
Beginning and converting recipes
Other than this, plant operators can in my opinion report specific occasions with the aid of an audit access function
Operation of pushbuttons and sliders
File pressing of a key
The Audit path database shops all the exchange records this is challenge to document manipulate; this includes consumer movements, confi guration adjustments and different adjustments. additives of Audit Trails include:
Date and time of the change
Venture identity, pc and database name
Old fee and the new one
Comment/reason for alternate
The system visualizes the Audit trail information by means of the Audit Viewer. Operators use filters to selectively set the preferred view of the Audit trail facts and they can export this statistics to an Excel file. The Audit path statistics is stored securely on a tamper-evidence foundation and which means you can not alternate or delete it. Which means WinCC/Audit meets the FDA requirements of 21 CFR component eleven on this admire too.
Monitoring undertaking adjustments is feasible with WinCC/Audit and with the option bundle WinCC/ChangeControl as nicely. in this connection, WinCC differentiates among configuration modifications that have an effect on the WinCC database, e.g. modifications in Tag management or growing a user organization and configuration adjustments which are limited to modifications to files, what is referred to as report control. document manage entails manner pictures, scripts and log layouts and customer-particular files. which means that WinCC/Audit can screen these kinds of files or files for adjustments, create intermediate versions or retrieve them using a rollback function. The whole tracking procedure can be activated very without problems and conveniently. which means in the case of plant standstills, as an example, plant engineers and operators can quickly and easily understand the modifications that have been made to the plant. This helps hassle-capturing and reduces plant downtimes.
WinCC tasks may be archived, restored and deleted,
WinCC facts which includes the undertaking database, undertaking files (e.g. monitors, reports, scripts) and user documents can be archived
activities of the project versioning device may be recorded
On this manner all modifications made to a plant starting from the production begin and persevering with during the complete existence cycle can be recorded and - using described variations - be documented.
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