Rockwell Automation RSBizWare Process Components Support 21 CFR Part 11 for electronic records and signatures

Complete automation leader Rockwell Automation has announced additional Rockwell Software Inc. products to help companies in the pharmaceutical, chemical and related industries meet FDA (Food and Drug Administration) Title 21 — Code of Federal Regulations — Part 11 (21 CFR Part 11) regulations. These regulations allow pharmaceutical companies to use electronic records and signatures in lieu of paper records and handwritten signatures for documentation.

• RSBizWare Batch™ provides efficient, predictable operation of batch processing, consistency between batches and generation of event information during batch runs. Leveraging S88 methodology and the principles of modular batch automation, users can reuse code, recipes, phases and logic between processes with similar procedures. RSBizWare Batch also allows users to generate batch logs that can be used to create reports for batch production analysis. This data can be distributed seamlessly across the enterprise to optimize operations.
  
• RSBizWare eProcedure™ integrates the execution of manual operations electronically, capturing operator actions and events, and providing a robust audit trail. Using this electronic signature capability users can capture quality deviations that may occur throughout both automated and manual processes.

"Pharmaceutical companies are moving toward an increasing use of electronic signatures to deliver greater productivity, faster cGMP parametric release of product, and compliance with FDA regulations," said Steve Ryan, process business, Rockwell Automation. "For our pharmaceutical and other consumer products customers who are affected by Federal regulations, we provide process-focused RSBizWare modules, as well as 21 CFR Part 11-compliant operator interface products such as RSView32™ and RSView32 Active Display System™."

In addition to these products, Rockwell Automation also provides customers with consulting services and in-house expertise to help implement systems that meet 21 CFR Part 11 regulations and take advantage of the cost savings of electronic documentation.

Rockwell Automation, a business of Rockwell International Corporation, helps industrial customers improve productivity and lower total costs through its combination of value-added services and product line competencies, which include: Allen-Bradley real-time control, Reliance Electric motors and drives, Dodge mechanical power transmission products, and information management through Rockwell Software. Rockwell Automation's Complete Automation™ approach is supported by thousands of authorized partners, distributors and solution providers around the world. More information about Rockwell Automation is available on the Web at www.rockwellautomation.com.

Rockwell is a $7.5 billion electronic controls and communications company with global leadership positions in industrial automation, avionics and communications, and electronic commerce. The company employs approximately 40,000 people at more than 450 locations serving customers in more than 80 countries.

Rockwell Software is the leading brand of software technology that helps automate factories and integrate them with the rest of the enterprise. This includes programming, human-machine interface, communications, information systems, process monitoring and control, and Internet technologies. Rockwell Software products are developed and supported in West Allis, WI. For more specific information about Rockwell Automation and its Rockwell Software products and services, go to http://www.software.rockwell.com. To order products our online store, visit www.rockwellautomation.com/rsstore.