规范是指产品、过程、服务或其他活动必须满足的任何要求。Р(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.Р确认是指通过检查和提供客观证据确认能够持续的满足指定用途的特殊要求。Р(1)?Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.Р过程确认是指通过客观证据确定过程能持续生产出满足其预先确定的规范要求。РDesign validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).Р设计确认是指通过客观证据来确定器械规范符合用户需求和预期使用用途。Р(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Р验证是指通过检查和提供客观证据以确认规定的要求是否得到满足。Р§ 820.5 Quality systemsР质量体系
全文预览
