Intellution launches consulting services
Staff -- Manufacturing Business Technology, 9/1/2001 12:00:00 AM
Intellution, a Foxborough, Mass.-based provider of industrial automation software, now offers a consulting service to help pharmaceutical manufacturers and other businesses regulated by the Food & Drug Administration (FDA) attain compliance with FDA regulation 21 CFR Part 11.
The vendor's 21CFR11 Consulting Services group will enable companies to create, implement, and maintain compliance with federal regulations that prescribe how electronic records and signatures are to be captured and stored in a secure way.
This service is an expansion of Intellution's Professional Services Group and part of the industry solutions being offered by Emerson Process Management, Intellution's parent company. The group addresses four support areas for compliance strategies: training, assessment, detailed detection, and maintenance.
"Meeting the requirements of 21 CFR Part 11 is a top priority for all FDA-regulated businesses—particularly pharmaceutical companies—but the changes are so sweeping that few know where to begin," says Bob Yeager, Intellution's president.
Sheila Kester, an Intellution vice president, adds that at present, the FDA is targeting pharmaceutical manufacturers for compliance, so this is the sector in which Intellution expects to see the highest initial demand for the services.
FDA takes risk-based stance on Part 11 rule
11/30/2003
