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Automated systems compute at GAMP Americas Forum

Insights from the August 22 Chicago Training and GAMP Americas Forum...

"More than 40 percent of software fails to meet user requirements," said Steven Coates, director/computer QA at Wyeth.

When gaining "buy-in" from Information Technology on computer compliance, "real-life benefits are more meaningful to IT than FDA 'sabre-rattling,'" noted Barbara Mullendore, director of corporate quality systems for Watson Pharmaceuticals.

"If you think computer compliance is a challenge," wait until security. "It's the next big business," said Robert Herr, manager, regulatory and quality for Pfizer's Animal Health Business Technology.

Michael Rutherford, manager of global quality labs at Eli Lilly & Co., said, "training is something industry doesn't take enough time on. It's expensive, and just when an employee is properly trained, there's [the potential for] turnover." He said a good employee requires a blend of on-the-job experience, training, and education. "Just giving them a template of what to do doesn't mean they'll know what they're doing. A fool with a tool is still a fool."

Robert Tollefsen, consumer safety officer with the Food and Drug Administration, agreed with Herr that the Quality Assurance department should be involved from the outset when it comes to automated computer systems and pharmaceutical validation processes. Tollefsen, who audits pharmaceutical facilities, said, "the FDA looks to organizations like ISPE to supply standards for automated systems. We don't necessarily endorse any one system."

The FDA's 21 CFR 11 regulations and guidance on electronic records and signatures are being rewritten, confirmed Tollefsen. He believed a draft would be made available for comment by the end of the year, although its release date is uncertain.

ISPE's annual meeting takes place Nov. 6-10 in Scottsdale, AZ.


The August 22, 2005 Chicago Training and GAMP Americas Forum in Itasca, IL, was held by the International Society for Pharmaceutical Engineers (ISPE), a society of nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. GAMP (Good Automated Manufacturing Practice) Forum is an ISPE sub-committee whose mission is to promote understanding of the regulation and use of automated systems within healthcare industries, including those used in packaging.

--By Jim Butschli, Editor
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