Boston Scientific anticipates that it will be ready for the FDA to audit its drug-eluting stent manufacturing operations and compliance systems by mid-2007, according to Chief Operating Officer Paul LaViolette.
The vast majority of FDA-regulated life sciences companies still believe computer system validation and 21 CFR Part 11 compliance are important even as agency enforcement lags, according to EduNeering CEO Donald Deieso.
Planned computer system change requires one set of tools and strategies for healthcare IT administrators, but it is the unplanned variety that causes most of the headaches, says a new whitepaper from Fluke Networks.
The near-universal use of Microsoft Excel spreadsheets in the pharmaceutical industry constitutes a serious compliance risk for companies that fail to validate them, expert David Harrison warned at a May 3 FDAnews audio conference.
Pharma companies should use risk analysis procedures to
decide which aspects of their computer systems need validation testing, rather than wasting time and money attempting to test everything, G. Raymond Miller, president of Miller Regulatory Consulting, said during a recent FDAnews audio conference.
People who have suffered the effects and risks of an irregular heartbeat for years can get long-lasting relief from a procedure that takes less than two hours, according to the March issue of the New England Journal of Medicine.