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Article: Checklists, code prompt FDA to dig deeper: consultant.(Food and Drug Administration, inspection of pharmaceutical industry computer systems)(Brief Article)
- Article from:
- Validation Times
- Article date:
- September 1, 1999
- Author:
CopyrightCOPYRIGHT 1999 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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PHILADELPHIA - FDA inspections of computer systems are turning up a number of deficiencies that may be a trend, industry learned here Sept. 13-15 at a Pharmaceutical Education & Research Institute (PERI) meeting.
At the top of the list is an absence of system requirements or specifications, said Dr. Robert Stotz, Ph.D., vice president, Validation Technologies, King of Prussia, PA.
He said FDA inspectors are also finding inadequate or no validation documentation for computer systems and software. Firms are being cited for not testing alarms or error conditions.
"In some cases, inspectors have found that the same individual writes, revises and ...