Items Tagged with 'Validation'

ARTICLES

Unvalidated Spreadsheets Are Compliance Risk

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.

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Using Risk Analysis to Simplify Computer Validation

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.

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Study: RF Catheter Ablation Procedure Gets Thumbs Up

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.

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