Simplifying Global Compliance
Items Tagged with 'Validation'
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. Read More
As part of a legal settlement, Novartis will assist Bayer Schering Pharma in obtaining FDA validation of Bayer’s outsourced European Betaseron manufacturing facility, Bayer told DID March 27. Read More
The medical device industry is catching up to other industries in the area of automation for more efficient manufacturing. Read More
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. Read More
Enterprise resource planning (ERP) systems can benefit FDA-regulated companies but their complexity and regulatory challenges can derail a company’s efforts, says ERP expert Bill Fitch. Read More
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. Read More
Biologics manufacturer Genentech will utilize tools from Honeywell to supply an integrated manufacturing control system, Honeywell said May 16. Read More
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. Read More
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. Read More
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. Read More
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