WinCC flexible/Audit
Traceability and easy validation

"Ready for Validation" now also applies to machine-level applications. The WinCC flexible/Audit option covers the main requirements of GMP (Good Manufacturing Practice) and of the US Food and Drug Administration (FDA) for compulsory validation of applications according to CFR 21 Part 11 in the pharmaceutical industry, to active ingredient manufacture in the pharmaceutical industry and to some extent in the cosmetics industry.

optional for HMI devices from series 270 upwards and for PC-Systems under WinCC flexible Advanced

Apart from this, WinCC flexible/Audit is also interesting for manufacturers active in the food, beverages and tobacco industry who want to set up their plants on a subject to compulsory validation basis in good time to be able to comply with future legal requirements.

Benefits:

Conforms to the requirements of the Food and Drug Administration (FDA) for the pharmaceutical industry
Reduced time and effort for engineering and validation
Available for Panels and Multi Panels of the 270 Series and above as well as for PCbased solutions
Matched in an optimum way for mechanical and plant engineers who must meet strict quality requirements with regard to the products to be manufactured as well as to the manufacturing process (e.g. when supplying machines and plant subsystems in applications that are subject to compulsory validation)

Secure access control including electronic signature

Even the basic system guarantees access protection which means that only authorized personnel have access within the scope of their responsibility at the operator panel. In this context, each user is assigned to a user group with defined function privileges on the system. This prevents unauthorized users, from changing recipes or starting process steps without permission, for example.

Since the FDA specifies that all activities in the plant must be uniquely assigned to specific individuals, the login and logout processes must be logged in the Audit Trail with a time stamp.
Apart from this, you must meet other regulations, e.g. twocomponent authorization comprising a user ID and password, password aging (to ensure that passwords are renewed on a regular basis), blocking users by the administrator and automatic Logout if users are inactive for a relatively long period of time. SIMATIC WinCC flexible 2005 in conjunction with SIMATIC Panels supports you in meeting the requirements for access control.

You can provide additional prompts for an electronic signature and a commentary in the case of operator actions like entering specied values or saving and loading recipes. This is of course automatically logged in the Audit Trail.

Recording operator actions 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. Operator actions of this type can include, for example, entering process values, starting recipes or acknowledging messages, as well as messages from user management like logging a user on and off.

Setting of GMP-relevant Tags

It is possible to visualize in a userfriendly way the Audit Trails that are registered in the project using a viewer. Then you can see exactly who operated what and when - all this with a minimum of configuration effort! Apart from this, a checksum is used to ensure that the data in the Audit Trail has not been tampered with.

Audit Trail represented by Audit Viewer

Tracking changes in manufacturing processes by means of Audit Trails is possible from series 270 Panels onwards. Two variants of the option package are offered:

WinCC flexible/Audit for Panels
WinCC flexible/Audit for PCs

Archiving and logging

WinCC flexible 2007 makes it possible to carry out archiving and logging in dependence on the requirements, i.e. on a local basis, or, in distributed systems on a central basis too. Local in this context means that the CSV files are stored on the operator device on site, while central means that the files are cyclícally transmitted to a PC in a control-room or a superior SCADA-system like WinCC. For this, there is support for solutions for longterm archiving and data recovery.

Additional information

"SIMATIC WinCC flexible - Flexibility in every HMI application"
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