WinCC 21 CFR

Siemens WinCC 21 CFR

Siemens SIMATIC WinCC 21 CFR is a SCADA and process visualization solution designed for industrial applications where electronic records, user access control, audit trails, data integrity and traceability are important requirements. WinCC provides tools for monitoring and controlling industrial processes while supporting the documentation of relevant operator activities and engineering changes.

WinCC 21 CFR is suitable for regulated and quality-sensitive manufacturing environments where process information and user activities need to be recorded and made traceable. The solution can support industrial automation systems requiring controlled access, event logging and documented changes throughout the plant lifecycle.

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OVERVIEW

SIMATIC WinCC provides comprehensive visualization and supervisory control capabilities for industrial automation systems. Depending on the selected WinCC configuration and options, relevant operator activities, system events and engineering changes can be recorded for later review.

For applications requiring compliance with regulatory requirements such as FDA 21 CFR Part 11, appropriate system configuration, validation procedures, access controls and organizational processes are essential. WinCC 21 CFR-related functionality can help provide the technical mechanisms required for traceability and controlled electronic records.

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ADVANTAGES

 Improved traceability of relevant system activities
Centralized visualization and process monitoring
Better visibility of operator and engineering activities
Support for controlled user access
Improved documentation of system changes
Efficient investigation of process and operational events
Support for validation and regulated automation projects 

 

DESIGN AND CAPABILITIES

Audit trail and event recording
Traceability of relevant operator activities
User access and authorization management
Electronic records and process data handling
Alarm and event monitoring
Recording of relevant engineering and configuration changes
Audit trail review and filtering
Process visualization and supervisory control
Integration with Siemens SIMATIC automation systems

 

AUDIT TRAIL

An audit trail provides a historical record of relevant activities and changes that need to be traceable. Depending on the system configuration, recorded information may include date and time, user identification, activity or event, previous and new values, system or project information and comments or reasons for changes.

Authorized users can review recorded audit information to help investigate process events, verify changes and maintain traceability throughout the operational lifecycle of an industrial system.

 

USER MANAGEMENT AND ACCESS CONTROL

Controlled user access is an important part of regulated industrial automation applications. WinCC can be configured with user management and authorization mechanisms to restrict access to functions and process information according to defined user roles and responsibilities.

Proper user management helps organizations maintain accountability by associating relevant activities with authorized users and supporting controlled operation of the SCADA system.

MONITORING OPERATOR ACTIVITIES

WinCC can record relevant operator activities performed during runtime operation. Depending on the configured application, this can include actions associated with process operation, recipes, alarms, user management and other configured functions.

Recording relevant activities provides greater visibility into operational events and helps plant personnel review changes and activities when troubleshooting, investigating incidents or maintaining process documentation.

 

MONITORING ENGINEERING AND PROJECT CHANGES

For industrial plants, maintaining traceability of engineering and configuration changes is important for controlled system maintenance. WinCC-related audit and change-control functionality can help organizations identify and document relevant changes made during the engineering and maintenance lifecycle.

Documented changes can assist engineers and plant operators in understanding modifications made to the automation system and can support troubleshooting, maintenance activities and change management procedures.

 

21 CFR PART 11 APPLICATIONS

WinCC 21 CFR solutions can be considered for industrial applications where electronic records and electronic signatures or related controls are required. The overall compliance of an application depends on the complete system architecture, software configuration, validation, procedures, user management and organizational controls.

WinCC should therefore be implemented as part of a properly designed and validated automation system rather than being considered as a standalone guarantee of regulatory compliance.

 

INDUSTRIAL APPLICATIONS

• Pharmaceutical manufacturing
• Life sciences and biotechnology
• Food and beverage processing
• Chemical and process industries
• Water and wastewater treatment
• Batch manufacturing
• Manufacturing and production plants
• Regulated industrial automation systems

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SIEMENS WINCC 21 CFR SUPPLIER

GRUPS Automation supplies Siemens industrial automation and SCADA solutions for manufacturing and process industries. We provide assistance for Siemens WinCC, WinCC Audit and WinCC 21 CFR-related applications, including product selection, technical requirements and industrial automation solutions.

Contact GRUPS Automation for Siemens WinCC 21 CFR product availability, technical assistance and quotation requirements.

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RELATED SIEMENS WINCC SOLUTIONS

• Siemens SIMATIC WinCC
• Siemens WinCC Audit
• Siemens WinCC ChangeControl
• Siemens WinCC Runtime
• Siemens WinCC SCADA Solutions