SIEMENS WinCC 21 CFR Part 11 Dealer, Distributor, Supplier, Trader, Price And Shop

Siemens WinCC 21 CFR Part 11

Detail Of Product

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Regulated industries such as pharmaceuticals, biotechnology and food & beverage must comply with strict rules on data integrity, traceability and electronic records under FDA 21 CFR Part 11 and EU Annex 11. Every operator action, recipe change and process-critical value must be logged, time-stamped and, where required, digitally signed and attributable to a specific user.

Siemens WinCC 21 CFR Part 11 is a ready-to-use compliance option package for SIMATIC WinCC that bundles Audit Trail, Electronic Signature (Sign+) and User Administration through SIMATIC Logon into a single license. It records every operator action and configuration change in real time during runtime, and also tracks project changes made during engineering. Critical steps - such as recipe releases, setpoint changes or batch approvals - can be protected with an electronic signature, so the responsible user is captured against every change. All records are stored securely in the tamper-evident Audit Trail database and can be reviewed anytime using the Audit Viewer, helping plant operators and system integrators meet 21 CFR Part 11 and EU GMP Annex 11 requirements without building custom compliance logic.

Product Features

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Complete 21 CFR Part 11 compliance package for SIMATIC WinCC Runtime Professional / Advanced.

Audit Trail logs every operator action, parameter change and project modification with time stamp, old value, new value, user and reason for change.

Electronic Signature (Sign+) requires user confirmation and password/PIN entry for critical actions such as recipe changes, batch release or setpoint overrides.

User Administration via SIMATIC Logon for centralized, role-based access control and accountability.

Audit Viewer allows quick search, filtering and export of audit records for internal reviews and regulatory inspections.

Supports pharmaceutical, biotech, food & beverage and other FDA/EU regulated production lines.