Complying with US and European change control requirements, Part II.
Part I of this two-part article discussed the United States (US) and European quality system requirements for controlling changes to products, processes and documentation. Part II will discuss some change control problems that can occur, the elements that should be included in change control procedures and records and the requirements for notifying regulatory authorities of changes.
Donawa
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Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004282:Documentation; D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D005060:Europe; D006801:Humans; D013677:Medical Laboratory Science / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration