山東2008年驗(yàn)證總計(jì)劃-資料下載頁(yè)
2025-01-21 21:49本頁(yè)面
【正文】 ve, 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)。Members of Validation Team驗(yàn)證小組成員To carry out the validation activities, make record, report the incident, and assist drafting the validation protocol and report.按照方案實(shí)施驗(yàn)證、并做好記錄、例外情況及時(shí)匯報(bào)和記錄、協(xié)助起草驗(yàn)證方案和報(bào)告。 All Departmental Managers/所有部門(mén)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。 Training /驗(yàn)證培訓(xùn)Appropriate training must be given to facilitate the satisfactory performance of Validation and Qualification activities, including the Validation Plan, Validation Protocol and required skills. The training should follow the requirements specified in “Training Management”驗(yàn)證過(guò)程中，驗(yàn)證計(jì)劃、驗(yàn)證方案以及驗(yàn)證中應(yīng)該掌握的技能應(yīng)該進(jìn)行培訓(xùn)，培訓(xùn)應(yīng)遵循《培訓(xùn)管理辦法》。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。 The documents are checked by all members of Validation Committee.以上文件的審核由驗(yàn)證委員會(huì)全體成員審核。 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)。 The Validation Certificate is issued by QA Manager by referring to the Validation Report which will state the approved project.驗(yàn)證報(bào)告顯示驗(yàn)證符合要求的驗(yàn)證項(xiàng)目由QA經(jīng)理發(fā)放驗(yàn)證證書(shū)。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(shū) 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。一般包括：項(xiàng)目概述、驗(yàn)證的范圍、所遵循的法規(guī)標(biāo)準(zhǔn)，被驗(yàn)證的廠房設(shè)施、系統(tǒng)、生產(chǎn)工藝，驗(yàn)證的組織機(jī)構(gòu)，驗(yàn)證合格的標(biāo)準(zhǔn)，驗(yàn)證文件管理要求，驗(yàn)證大體進(jìn)度計(jì)劃等內(nèi)容。 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 calib
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