7-User-Requirement-Specification-and-Design-Qualification

First level,Second level,Third level,Fourth level,Fifth level,Click to edit Master title style,NOVOZYMES PRESENTATION,*,*,13-01-2010,1,User Requirement Specification and Design Qualification,用户需求标准和设计确认,13-01-2010,2,User Requirement Specification and Design Qualification,用户需求标准和设计确认,On completion of this module,you will be able to:,完成这个模块以后你将能够：,State the requirements of a URS and the Associated FS,能够陈述用户需求标准的要求和生产制造中相关的制造程序（,FS,）,Understand the fundamentals of URS compilation and how to map them against the Functional Specifications and Design Specifications,了解,USR,汇编的基本原理，并针对功能规格和设计规范将它们勾画出来。,Develop a URS and evaluate a FS,开发一个,USR,评估一个,FS,State the requirements of a Design Qualification(DQ),陈述设计确认的要求,Understand the fundamentals of DQ compilation,了解,DQ,汇编的基本原理,Develop a DQ for a production equipment,为生产设备开发一个,DQ,Apply risk management principles to qualification,在资格证书中应用风险管理原则,13-01-2010,3,Design qualification,设计确认,Is based on,基于,Is based on,基于,Is based on,基于,User specification,用户说明书,Functional specification,功能说明书,Design specification,设计说明书,PQ,QQ,IQ,Implementation,启用,commissioning,调试,“,V Model”for Validation-Relationship,确认关系的“,V,模型”,13-01-2010,4,User Requirement Specification and the functional specification,用户需求标准和功能标准,Users responsibility,用户责任,This is what we want“,“这是我们所需要的”,Functional Requirements Specification,功能需求标准,Suppliers responsibility(or the group with the solution),供应商的责任（有解决方案的人们）,-Did we get what we wanted I needed?,This is what we can give you“,这是我们能给你们的”,Requirements Traceability Matrix-Part1,需求追踪矩阵,-,第一部分,-Did we get what we wanted I needed,我们得到我们所需要的了吗？,13-01-2010,5,User Requirement Specification,用户需求标准,A formal statement of what all the users want and/or expect from the system,是所有的用户都想从系统中得到的正式声明,Identifies what requirements are mandatory and what requirements are desirable.,确定哪些需求是强制性的那些是合意的,Users will include personnel from manufacturing,control engineering IT,regulation and QA functions,用户将包括制造、控制、工程、计算机、管理还有质量保证职能人员,Written in plain English,用朴实的英语来写,Clauses should be numbered(legal system)for ease of traceability,为便于追踪，条款（法律）应该被编号,It is the document that PQ is based on,性能确认基于此文件,Prepare from a template,从一个模板准备,13-01-2010,6,User Requirement Specification,用户需求标准,GENERAL GUIDELINES,基本指南,一,Each requirement statement to be uniquely referenced,and no longer than 250 words,to aid traceability,每个需求声明都是唯一被参考的，并且不超过,250,个字，以便追踪。,一,Requirement statements should neither be duplicated nor contradicted,需求声明既不能重复也不能有矛盾,一,The URS should express requirements and not design solutions,USR,应该明确需求而不是设计解决方案,一,Each GxP requirement should be testable or verifiable in some way,每一个,GxP,需求都可以用某种方法来测试或者核查,一,The URS must be understood by both user and supplier;ambiguity and jargon should be avoided,用户和供应商都应该了解,USR,需求，应该避免模棱两可的话和行话。,Wherever possible,requirements should be prioritized,The USR should distinguish between essential requirement and merely desirable features,只要有可能，需求应当优先，,USR,应当区分本质需求和仅仅是期望,13-01-2010,7,Contents of the URS Document USR,文件的内容,Approve,认证,Introduction Section,引言部分,Overview Section,概述部分,Product Description,产品描述,Process Description,工艺描述,Regulator Requirements and Other Standards,规范需求和其他标准,Operational Requirements Section,操作要求部分,一,Process Requirements,工艺要求,一,Functions,功能,一,Critical Parameters,关键参数,一,Documentation Requirements,需求文件,一,Constraints,限制,Glossary Section,词汇部分,13-01-2010,8,USR operational requirement USR,操作需求,13-01-2010,9,Exercise Number 1,练习,1,Using the notes to assist you compile a URS for a powder-liquid blender,用这些注解来帮助你为一个粉末液体搅拌机编译一个,USR,13-01-2010,10,Functional Specification,功能确认,Identifies the best solution to achieve the users requirements.,确定最佳解决方案来满足顾客的需要,Maps directly to the user requirements via the clause numbering system,通过条款编码系统直接映射出用户需求,Defines how the system will function and what the operating parameters are.,确定系统是怎么起作用的，运行参数是什么,Prepared by(potential)Vendor(s)and/or the Project Team,潜在供应商或者项目小组拟定,It is the basis for Operational Qualification tests,这是,OQ,测试的基础,Where practical,prepare in accordance with a template,如果现实，按照模板进行准备,13-01-2010,11,Design Specification(s),设计确认,A detailed description from which the system or equipment can be built or the process developed.,一个使系统和设备得以建立，工艺得到发展的详细说明,It is a technical document.,这是一份技术性文件,It is the basis for Installation Qualification.,这是安装确认的基础,It should map directly to the Functional,Requirements via the clause numbering system(often not practical),通过条款编码系统可以直接映射到功能需求（通常不实用）,13-01-2010,12,Design Qualification(DQ),设计确认,(DQ),The documented verification that the proposed design of the facilities,systems and equipment is suitable for the intended purpose.,文件核实拟设计的设施、系统和设备与预期目的相一致。,13-01-2010,13,Design Qualification,设计确认,Will the design work?,设计起作用吗？,Is it suitable for the intended use?,能否达到预定的要求？,Have the facilities/supporting utilities/equipment/process been designed in accordance with the requirements of GMP?,配套设施、公用事业、设备和工艺是不是按照,GMP,的要求设计的？,Is it validatable?,是否可校验？,13-01-2010,14,Design Qualification,设计确认,Have we designed w