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PubMed · 10186986

Process validation: harmonizing the requirements.

M E Donawa
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Abstract

Medical device manufacturers marketing in Europe and the United States are faced with differing expectations regarding the quality system requirements for process validation. However, this may change as a result of a process validation guidance document being developed by the Global Harmonization Task Force. This article will discuss the document's current status, some of its elements and some suggested modifications.

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Equipment and SuppliesEuropeGuidelines as TopicHumansOutcome and Process Assessment, Health CareProduct Surveillance, PostmarketingUnited StatesJournal Article

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M E Donawa. 1998. Process validation: harmonizing the requirements.. https://pubmed.ncbi.nlm.nih.gov/10186986/

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