What WinCC 21 CFR Adds to a Standard WinCC System

Compliance Features

• Secure, tamper-evident audit trail of operator actions and parameter changes

• Configurable electronic signature workflows

• User identity and timestamp binding on logged events

• Electronic record generation aligned to 21 CFR Part 11

• Works as an add-on to an existing WinCC Runtime license

Typical Applications

• Pharmaceutical manufacturing lines

• Biotech and bioprocessing

• Medical device production

• Food & beverage batch processes with regulatory traceability needs

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License & Option Range

License / OptionDescription
WinCC 21 CFR Part 11 Option Base Compliance License (electronic records, audit trail, e-signature)
WinCC 21 CFR RT 128 PowerTags Entry-Level Compliant Runtime
WinCC 21 CFR RT 512 PowerTags Small System Compliant Runtime
WinCC 21 CFR RT 2048 PowerTags Mid-Size Compliant Runtime
WinCC 21 CFR RT 8192 PowerTags Large System Compliant Runtime
WinCC 21 CFR Server Option Multi-User Compliant Server License
WinCC 21 CFR RC Client Remote Configuration Client (compliant)
WinCC 21 CFR Audit Trail Add-on Extended Audit Trail / Electronic Signature Module

Contact us for a current price list — pricing depends on PowerTag count, server/client configuration, and which compliance modules you need.

Why Work With Swastyprasad Engineering

✔ Genuine Siemens licensing

✔ Configuration and licensing guidance from people who understand Part 11 requirements

✔ Based in Vasai/Mumbai, serving Vasai, Mumbai, Thane, Navi Mumbai, Pune, Delhi, Ahmedabad and open to export inquiries elsewhere

✔ Support through selection, licensing and commissioning

Communication & Programming Interfaces

CategoryDetails
Controller connectivityS7-300/400, S7-1200/1500, OPC, OPC UA, Modbus TCP, and other common industrial protocols supported by the WinCC base platform.
IT integrationOLE-DB, OPC UA, MQTT and REST interfaces for connecting WinCC data to higher-level IT/MES systems.
Scripting/programmingVBA, VBScript, C-API (ODK) and C-Script (ANSI-C) for customizing WinCC behavior.

Get a Quote for Siemens Simatic WinCC 21 CFR

Tell us your PowerTag count and whether you need Server, RC Client or audit-trail add-on options, and we'll put together a licensing quote.

Request Quote Call Now

Frequently Asked Questions — Siemens Simatic WinCC 21 CFR

1. What is Siemens Simatic WinCC 21 CFR?
WinCC 21 CFR is an add-on option for Siemens Simatic WinCC that brings the software into alignment with FDA 21 CFR Part 11 requirements — electronic records, secure audit trail, and electronic signatures.

Contact us for pricing and availability.

2. Who needs WinCC 21 CFR Part 11 compliance?
Typically pharmaceutical, biotech, medical device and food & beverage manufacturers who need to demonstrate traceable, tamper-evident electronic records to regulators such as the FDA.
3. What does the audit trail record?
Operator actions, parameter changes and system events, each bound to a user identity, timestamp and (where configured) a reason for the change — stored in a way that resists tampering or deletion.
4. Does WinCC 21 CFR require electronic signatures?
The option supports configurable electronic signature workflows so operators can confirm critical actions in line with Part 11's requirements for signed electronic records.
5. Can it be added to an existing WinCC installation?
Generally yes — it's licensed as an add-on option on top of a base WinCC Runtime license, so an existing system can usually be extended rather than reinstalled from scratch.

Ask us about your specific setup.

See also: Siemens products overview and Siemens Simatic WinCC (standard).