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  • Title: Taking control: the Validation Master Plan.
    Author: Donawa ME.
    Journal: Med Device Technol; 1995 Dec; 6(10):12-4. PubMed ID: 10158118.
    Abstract:
    Companies preparing for compliance with the European quality system standards and US Good Manufacturing Practice regulations must comply with the process validation requirements that apply to their manufacturing processes. Effective planning for compliance is fundamental for companies with processes that must be validated, monitored, and controlled. This article discusses the basic elements of a Validation Master Plan, which can greatly facilitate this planning process.
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