Complying with US and European change control requirements, Part Ii
Donawa, M.E.
Medical Device Technology 8(9): 13-16
1997
ISSN/ISBN: 1048-6690 PMID: 10174625 Document Number: 471256
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.
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