Complying with 21 CFR Part 11 with FactoryTalk® View Machine Edition 10.00

In 1997 the Food and Drug Administration (FDA) issued the final rule on the criteria under which the Agency will accept electronic signatures and records in place of handwritten signatures and records executed on paper. The scope of this regulation, US FDA 21 CFR Part 11, is significant and impacts all computer systems related to the manufacturing of a life science product (for example, oral solid dosage, biologic, or medical device). According to the rule, “This Part (21 CFR Part 11) applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted.”

FactoryTalk® View ME 10.00 adds functionality designed for applications that must comply with 21 CFR Part 11. These enhancements were explicitly made to overcome compliance obstacles that exist in earlier versions of FactoryTalk View ME.

Onboard Audit
The new onboard audit feature records and stores operator’s actions locally. Locally storing the audit log allows the system to overcome the challenges of complying with 21 CFR Part 11 using FactoryTalk® AssetCentre as the FactoryTalk View ME audit log repository.

Export Logs to CSV
The system can export the audit history, alarm history, and diagnostic log to a CSV file. This information can be used to generate an electronic batch record.

Audit and Alarm History Capacity Triggers
Since the audit and alarm history are circular buffers, each with a 10,000 record maximum size, v10.00 introduces capacity triggers. The capacity triggers can be used to signal to the system or operator when the circular buffers reach a setpoint (percentage based). For example, the High Capacity trigger can be used to trigger an alarm when it is reached.

 

Resources

To help you meet 21 CFR Part 11 compliance, Rockwell Automation has a few useful resources.  First is a white paper that discusses 21 CFR Part 11 and how to comply using FactoryTalk Machine Edition Version 10.00.  The second is a series of YouTube videos that show the configuration steps you would take in FactoryTalk Machine Edition and on a PanelView Plus.

Complying with 21 CFR Part 11 White Paper:

Complying with 21 CFR Part 11 Video Series:

Configure Application Security

Configure Inactivity Logout

Using Electronic Signature to Control and Record Write Actions & Viewing Audit Messages Locally

Test e-Signatures and Audit Log Features & Tamper Detection of Audit Logs

 

Photo by Louis Reed on Unsplash

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