Did you know? FactoryTalk View ME 10.00 adds enhancements for 21CFR Part 11.

In the version 10 release of FactoryTalk View ME earlier this year there were a few hidden enhancements you may not have known of.  One key one, support for 21CFR Part 11, is big.  Many of our customers, including maybe you if you are reading this, have been asking for it for quite some time.  This enhancement was made specifically to overcome compliance obstacles for smaller Machine Edition applications.

Traditionally, a full FactoryTalk AssetCentre implementation was needed to meet compliance.  But what if you had a simple, standalone solution or machine?  Here is when View ME Version 10 comes in.

New Feature Compliance Highlights:

• Onboard Audit – The new onboard audit feature locally records and stores operator’s actions. This rids the need for FactoryTalk® AssetCentre in many operations.
• Export Logs to CSV – The audit history, alarm history, and diagnostic can log to a CSV file.
• Audit and Alarm History Capacity Triggers – The audit and alarm history are circular buffers, each has a 10,000 record maximum size.

Now, you may still want to consider a full implementation with FT AssetCentre.  When might you do that?  Here are 5 key times:

1. More than 10,000 records are needed for an audit trail.
2. Backup of PLC/HMI and other project files automatically including 3rd party devices.
3. Version control of current projects loaded in devices.
4. Complete Restore of projects using “Disaster Recovery” add-on.
5. Calibration Management of devices assisting with validated systems.

Compliance that FactoryTalk View ME Version 10 offers

21 CFR Part 11 dictates the storing of both the records and signatures electronically while consistently maintaining the integrity of the data files.  These files must portray any evidence of tampering to assure they’re intact.  The FDA has insisted on the assurance of the data integrity to satisfy compliance with the Part 11 of the regulation.  If any portion of the data files are modified after recording is complete, the data becomes invalid.

Rockwell Automation has worked intensely to offer such compliance in any of the PanelView Plus 6 or 7 models using Version 10.00.  Details on how the Version 10 of Machine Edition achieves this, please refer to page 6, second paragraph 21 CFR Part 11 Compliance Qualitive Summary in the 1^st Rockwell Automation’s Whitepaper below, “FT View Machine Edition 10.0, Complying with….”.  This will assist to ensure the all expectations are met.

Reference documents to read up and get you going:

• FTView Machine Edition (ME) 10.0, Complying with 21 CRF Part 11: Electronic Records & Signatures
• FTView Site Edition (SE), Guidelines for Applying View SE in a 21 CFR Part 11