山東2008年驗(yàn)證總計(jì)劃(參考版)
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【正文】 Validation Protocol/驗(yàn)證方案It is a written protocol stating how to validate and specifying the acceptance criteria. The Validation Protocol generally includes three main parts: the validation project summary which describes the specific contents to be checked calibra。5 Documentation/文件 Content/文件范圍The documentation is promised of Validation Plan, Validation Protocol, Validation Report and Validation Certificate文件包括驗(yàn)證計(jì)劃、方案、報(bào)告、證書 Validation Plan/驗(yàn)證計(jì)劃It consists of Validation Master Plan, Individual Validation Plan and Annual Validation Plan, which describe the plan and requirements for individual or annual validation activities. A Validation Plan generally includes the project summary, validation scope, regulatory and statutory requirements, validated project, validation organizational chart, acceptance criteria, documentation requirements and schedule, etc.包括驗(yàn)證總計(jì)劃、分項(xiàng)的或年度的驗(yàn)證計(jì)劃，是對(duì)某個(gè)項(xiàng)目或者某個(gè)年度的驗(yàn)證工作的規(guī)劃和要求。 The Validation Plan, Protocol and Report are approved by Technical Director.所有驗(yàn)證計(jì)劃、方案、報(bào)告均由技術(shù)總監(jiān)批準(zhǔn)。4 The Writing and Approval of Validation Plan, Protocol and Report/驗(yàn)證計(jì)劃、方案、報(bào)告的起草審批程序 The Validation Plan is written by Validation Manager, Validation Protocol and Validation Report are written by Validation Team Member.驗(yàn)證計(jì)劃由驗(yàn)證經(jīng)理起草，驗(yàn)證方案和報(bào)告由驗(yàn)證小組組織起草。 All Departmental Managers/所有部門經(jīng)理職責(zé)Completion of Validation/Qualification projects relating to their areas.完成與其區(qū)域相關(guān)的驗(yàn)證/確認(rèn)工作。 Responsibilities of Validation Team/驗(yàn)證小組職責(zé)：Personnel/人員Responsibilities/職責(zé)Team Leader驗(yàn)證組長(zhǎng)To draft the Validation Protocol and Report, organize the individual validation activities, arrange the validation archive, organize the training and ensure the Team Member can keep the record in detail according to the protocol requirements.起草驗(yàn)證方案、組織項(xiàng)目的具體驗(yàn)證、督促驗(yàn)證小組成員按照驗(yàn)證方案的要求做好驗(yàn)證記錄、起草驗(yàn)證報(bào)告、整理驗(yàn)證檔案，組織相關(guān)的驗(yàn)證培訓(xùn)。根據(jù)批準(zhǔn)的驗(yàn)證報(bào)告發(fā)放驗(yàn)證合格證書。QA ManagerQA經(jīng)理Ensuring that all Validation amp。Other members in the Validation Committee驗(yàn)證委員會(huì)其他成員Ensuring that products are manufactured using Validated Equipment, Facilities, Processes, Test Method and Systems To check the Validation Plan, Protocol and Report. 確保正式生產(chǎn)使用的設(shè)施、設(shè)備、工藝、檢驗(yàn)方法和系統(tǒng)經(jīng)過(guò)驗(yàn)證。Validation Manager驗(yàn)證經(jīng)理To coordinate validation and qualification projects, draft the VMP, ensure the Validation Team pleting the validation, and establish validation archive.協(xié)調(diào)驗(yàn)證和確認(rèn)工作，起草驗(yàn)證總計(jì)劃，督促各驗(yàn)證小組按照計(jì)劃和方案完成驗(yàn)證，建立驗(yàn)證檔案。組長(zhǎng)一般由驗(yàn)證經(jīng)理根據(jù)實(shí)際情況指定，小組成員由驗(yàn)證組長(zhǎng)在起草驗(yàn)證方案時(shí)根據(jù)要求指定。 Validation Manager is responsible for cocoordinating.
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