生产新机器验证管理 Production new machine validation management

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需求分析：明确新机器的功能需求、性能标准和合规要求，确保所有相关方达成共识.



Requirement analysis: Clarify the functional requirements, performance standards, and compliance requirements of the new machine to ensure consensus among all relevant parties

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验证计划：制定详细的验证计划，包括验证的范围、方法、时间表和责任人.



Verification Plan: Develop a detailed verification plan, including the scope, methods, timeline, and responsible persons for the verification

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• 设计验证：在机器设计阶段进行验证，确保设计符合初始需求。可以通过模拟、原型测试等方法进行。

  
  

Design validation: Conduct validation during the machine design phase to ensure that the design meets the initial requirements. It can be done through simulation, prototype testing, and other methods.

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安装验证：在机器安装后，进行安装验证，确保设备按照规范安装并正常运行.



Installation verification: After the machine is installed, perform installation verification to ensure that the equipment is installed according to specifications and runs normally

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• 运行验证：进行运行验证，验证机器在实际生产条件下的性能，确保其达到预期的生产能力和质量标准。

  
  

Operational validation: Conduct operational validation to verify the performance of the machine under actual production conditions, ensuring that it meets the expected production capacity and quality standards.

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文档管理：所有验证过程和结果都应记录在案，以便于追溯和审计。确保文档的完整性和准确性.



Document management: All verification processes and results should be documented for traceability and auditing purposes. Ensure the completeness and accuracy of the document

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培训与支持：对操作人员进行培训，确保他们理解机器的操作和维护要求，提供必要的技术支持.



Training and Support: Train operators to ensure they understand the operation and maintenance requirements of the machine, and provide necessary technical support

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• 持续监控：在机器投入生产后，持续监控其性能，及时发现和解决潜在问题。

  
  

Continuous monitoring: After the machine is put into production, its performance is continuously monitored to promptly identify and solve potential problems.

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反馈与改进：收集使用过程中的反馈信息，进行分析和改进，优化机器的性能和可靠性.



Feedback and improvement: Collect feedback information during use, analyze and improve, optimize machine performance and reliability

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