計算機化系統(tǒng)驗證要點分析

1、1/89目錄 Table of Contents 3.新建及遺留計算機化系統(tǒng)驗證示例分析 Case Study for Validation of New and Legacy Computerized Systems2.新建計算機化系統(tǒng)驗證流程介紹 Introduction to Validation Process of New Computerized SystemTable of Contents 1.計算機化系統(tǒng)相關(guān)法規(guī) Computerized System Related Regulations 計算機化系統(tǒng)驗證要點分析Key-Point Analysis of Computer

2、ized System ValidationAnwar奧星設(shè)備與工藝系統(tǒng)事業(yè)部 驗證總監(jiān)3/89計算機化系統(tǒng)相關(guān)法規(guī) Computerized System Related Regulations第一部分 Part 14/89相關(guān)法規(guī)和指南總覽 Relevant Regulations and Guidelines (US FDA) 21CFR Part11 美國聯(lián)邦法規(guī)21篇第11部分電子記錄與電子簽名 (US FDA) 21CFR Part11: Electronic record and electronic signature (US FDA)工業(yè)指南 11部分 電子記錄與電子簽名-范

3、圍和應用 (US FDA) Guidance for Industry, Part11 Electronic record and electronic signature scope and application (US FDA) 聯(lián)邦法規(guī)第21篇第210 211部分，成品藥的現(xiàn)行生產(chǎn)質(zhì)量管理規(guī)范 (US FDA) 21CFR Part 210 and 211, cGMP for finished pharmaceuticals (ISPE) 良好自動化生產(chǎn)實踐指南，遵從GxP計算機化系統(tǒng)監(jiān)管的風險管理方法 (ISPE) GAMP, A risk-based approach to a G

4、xP compliant Computerized system (ISPE)GAMP GPG 良好實踐指南，GAMP架構(gòu)下的系列良好實踐指南 (ISPE)GAMP GPG , GPG under the framework of GAMP (EU)歐盟藥事法規(guī)第4卷GMP，附錄11計算機化系統(tǒng) EU Guidelines to Good Manufacturing Practice: (Volume 4), annex 11 Computerized System (PIC/S)GMP指南，藥用產(chǎn)品良好生產(chǎn)實踐指南 (TGA)GMP，藥用產(chǎn)品良好生產(chǎn)實踐指南(PIC/S)在“GxP”監(jiān)管環(huán)境

5、下的計算機化系統(tǒng)良好實踐（檢查官指南） PIC/S Computerized system good practices under GxP regulation( Inspector guideline) (WHO) GMP 2003, Annex 4 (WHO Technical Report Series, No. 908) (CFDA) 2010年版GMP 及征求意見稿計算機化系統(tǒng) CFDA GMP-2010 and “ Computerized System”(draft for comment)(CFDA) GSP附錄二附錄三藥品經(jīng)營企業(yè)計算機系統(tǒng)溫濕度自動監(jiān)測 (CFDA) GS

6、P Annex 2 and Annex 3 “ Computerized System of Pharmaceutical Trading Enterprises” and “Automatic Temperature and Humidity Monitoring”5/89CFDA GMP及附錄 CFDA GMP and Annexes第一百六十三條使用電子數(shù)據(jù)處理系統(tǒng)的，只有經(jīng)授權(quán)的人員方可輸入或更改數(shù)據(jù)，更改和刪除情況應當有記錄；應當使用密碼或其他方式來控制系統(tǒng)的登錄；關(guān)鍵數(shù)據(jù)輸入后，應當由他人獨立進行復核。用電子方法保存的批記錄，應當采用磁帶、縮微膠卷、紙質(zhì)副本或其他方法進行備份，以確

7、保記錄的安全，且數(shù)據(jù)資料在保存期內(nèi)便于查閱。Article 163If an electronic data processing system is used, only authorized persons can input or change data, the change and deletion records shall be kept, the systems logging in shall be controlled by the way of inputting a password or other methods; after inputting key data,

8、 it shall be double checked by another person independently. The batch record stored electronically shall be backed up with a magnetic tape, a microfilm, a paper duplicate or other methods, to ensure the safety of the record and the convenience to review during the preservation period.附錄1第七十條 采用自控和監(jiān)

9、測系統(tǒng)的，應當經(jīng)過驗證，保證符合關(guān)鍵工藝的要求。 Article 70, Annex 1 Where automation and monitoring systems are used for these applications they should be validated to ensure that critical process requirements are met.6/89CFDA GMP征求意見稿計算機化系統(tǒng)CFDA Draft for comment “Computerized system”第四條 應使用科學的風險評估方法來決定計算機化系統(tǒng)驗證的范圍與程度。應當將驗

10、證看作計算機化系統(tǒng)“生命周期”的一個組成部分。Article 4 Science based risk assessment approaches shall be used to determine the scope and extent of computerized system validation. The validation shall be considered as a part of the “ lifecycle” of a computerized system. 第七條 軟件是計算機化系統(tǒng)的重要組成部分。軟件的使用者應當根據(jù)風險評估的結(jié)果，對于所采用軟件進行分級管理

11、（如針對軟件供應商的審計），保證軟件的編制過程符合質(zhì)量保證系統(tǒng)的要求。Article 7 Software is an important part of a computerized system. Users of software shall perform differentiated management (such as for audits to software suppliers) to the software used based on the risk assessment results, to ensure the programming process of so

12、ftware conforms to the requirements of the quality assurance system.第十條數(shù)據(jù)的輸入或修改只能由經(jīng)許可的人員進行。杜絕未經(jīng)許可的人員輸入數(shù)據(jù)的手段有：使用鑰匙、密碼卡、個人密碼和限制對計算機終端的訪問。Article 10 Only an authorized person is allowed to input or change data. Means to prevent unauthorized personnel from inputting data includes: key, cipher card, pers

13、onal password and restriction to access to computer terminals.7/89EU GMP Annex11計算機化系統(tǒng)4.6定制計算機系統(tǒng)的驗證，應有一個適當?shù)倪^程保證在系統(tǒng)所有生命周期的階段進行正式的評估和質(zhì)量和性能測試的報告。4.6 For the validation of customized computerized systems there should be a step in place that ensures the formal assessment and reporting of quality and perf

14、ormance measures for all the life-cycle stages of the system9.審計跟蹤 Audit Trails9. 應該基于風險評估來考慮給系統(tǒng)加入一種可以生成記錄的功能，來記錄所有與GMP相關(guān)的變更和刪除（系統(tǒng)生成的“審計跟蹤”）。Consideration should be given, based on risk assessment, to building into the system a function for the creation of a record of all GMP-relevant changes and de

15、letions (an audit trail generated by the system).12.1應該使用物理和/或邏輯控制來嚴格控制計算機系統(tǒng)的權(quán)限，其權(quán)限只給經(jīng)過授權(quán)的人。12.1 Physical and/or logical controls should be in place to restrict the access to a computerized system only to authorized persons.8/89US 21 CFR Part21121168自動化設(shè)備、機械化設(shè)備和電子設(shè)備應對計算機或有關(guān)系統(tǒng)采取適當控制，以確保生產(chǎn)及控制主記錄或其它記錄由

16、授權(quán)人員制定變更內(nèi)容。配方、其它記錄或數(shù)據(jù)在計算機或有關(guān)系統(tǒng)輸入和輸出時，應核查其準確性。21168 Automation equipment, mechanical equipment and electronic equipmentAppropriate controls shall be used for a computer or the related systems to assure that changes in the master production and control records or other records are instituted only by a

17、uthorized personnel. Input to and output from the computer or the related system of formulas or other records or data shall be checked for accuracy.9/89US 21 CFR Part11Sub B/11.10/a 系統(tǒng)的驗證以保證準確、可靠、穩(wěn)定地預期性能，有能力識別無效的和被改變的記錄。 Sub B/11.10/a Validation of systems to ensure accuracy, reliability, consistent

18、 intended performance, and the ability to discern invalid or altered records.Sub B/11.10/e使用安全的、計算機產(chǎn)生的、時間印記的審計跟蹤以便獨立地記錄操作者登錄和建立、修改、或刪除電子記錄的行為的日期和時間。 ) Sub B/11.10/e Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions

19、that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information.Sub B/11.10/g使用驗證檢查以保證只有被授權(quán)用戶才可以使用系統(tǒng)，以電子方式簽署記錄，使用操作或計算機系統(tǒng)的輸入輸出設(shè)備，改變記錄或手工執(zhí)行操作。Sub B/11.10/g Use of authority checks to ensure that only authorized individuals can use the system, electr

20、onically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.10/89WHO GMP15.9使用電子數(shù)據(jù)處理系統(tǒng)的，只有經(jīng)授權(quán)的人員方可輸入或更改數(shù)據(jù)，更改和刪除情況應當有記錄；應當使用密碼或其他方式來控制系統(tǒng)的登錄；關(guān)鍵數(shù)據(jù)輸入后，應當由他人獨立進行復核。用電子方法保存的批記錄，應當采用磁帶、縮微膠卷、紙質(zhì)副本或其他方法進行備份，以確保記錄的安全，且數(shù)據(jù)資料在保存期內(nèi)便于查閱。15

21、.9 If electric data processing system is used, only authorized person could input or change data, the change and deletion records shall be kept; the systems logging in shall be controlled by the way of inputting password or other methods; after inputting key data, it shall be double examined by othe

22、r person independently. The batch record stored in electronic method shall be backed up with magnetic tape, microfilm, paper duplicate or other methods, to ensure the safety of the record and it is convenient to review data during the preservation period.11/89ISPE GAMPGAMP5（ Good Automated Manufactu

23、ring Practice -Rev5）GAMP是由國際制藥工程協(xié)會主編的針對計算機化系統(tǒng)合規(guī)的實踐指南。旨在提供一套基于現(xiàn)有行業(yè)規(guī)范的行之有效的方法，使計算機化系統(tǒng)符合預定用途并滿足現(xiàn)有法規(guī)的要求。自90年代以來，不斷改版的良好自動化生產(chǎn)實踐指南已被廣泛使用并得到國際監(jiān)管部門的公認。它是計算機化系統(tǒng)驗證的指導方針。GAMP5是目前的最新版本，于2008年2月發(fā)布。GAMP is practice guideline edited by ISPE aiming to regulatory compliance of computerized system. GAMP guidance aims

24、 to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Since 1990s, constantly revised GMAP has been widely used and recognized by international regulatory authori

25、ties. It is the guideline to computerized system validation. Since its issuance in February 2008, GMAP 5 is the latest version up to now. 五個關(guān)鍵概念 Five key concepts ：基于質(zhì)量管理體系的生命周期方法 Life cycle approach within a QMS可增減的生命周期活動 Scaleable life cycle activities流程和產(chǎn)品的理解. Product and process understanding基于科

26、學的質(zhì)量風險管理 Science based quality risk management充分利用供應商活動. Leveraging supplier involvement12/89法規(guī)、GMP、驗證相關(guān)術(shù)語 Regulations, GMP , Validation related glossary 術(shù)語Abbr.名稱NameCFDAChina Food and Drug Administration國家食品藥品監(jiān)督管理總局WHOWorld Health Organization世界衛(wèi)生組織EUEuropean Union歐洲聯(lián)盟（歐盟）PIC/SPharmaceutical Inspe

27、ction Convention and Pharmaceutical Inspection Co-operation Scheme藥品檢查合作計劃 (藥品檢查協(xié)會）FDAU.S. Food and Drug Administration美國食品藥品監(jiān)督管理局ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use國際人用藥品注冊和醫(yī)藥技術(shù)協(xié)調(diào)會議ISPEInternational Society For Pha

28、rmaceutical Engineering國際制藥工程協(xié)會RARisk Assessments 風險評估SIASystem Impact Assessment 系統(tǒng)影響性評估術(shù)語Abbr.名稱NameCCAComponent Criticality Assessment 部件關(guān)鍵性評估FAT/SATFactory Acceptance Test /Site Acceptance Test 工廠/現(xiàn)場驗收測試DQ/IQ/OQ/PQDesign / Installation / Operational / Performance Qualification 設(shè)計/安裝/運行/性能確認CPPCr

29、itical Process Parameter 關(guān)鍵工藝參數(shù)CQACritical Quality Attribute關(guān)鍵質(zhì)量屬性ERESElectronic Record; Electronic Signature電子記錄與電子簽名13/89計算機化系統(tǒng)驗證常見術(shù)語1 Common Glossary for Computerized System Validation 1名稱 縮寫英文 驗證主計劃 VMP Validation Master Plan 質(zhì)量及項目計劃QPPQuality and Project Plan用戶需求說明 URS User Requirement Specific

30、ation 功能說明 FS Function Specification 硬件設(shè)計說明HDSHardware Design Specification軟件設(shè)計說明SDSSoftware Design Specification軟件模塊說明SMSSoftware Module Specification設(shè)計確認 DQ Design Qualification 源代碼審核SCR Source Code Review軟件模塊測試SMTSoftware Module Test工廠驗收測試 FAT Factory Acceptance Test 現(xiàn)場驗收測試 SAT Site Acceptance Te

31、st 安裝確認IQInstallation Qualification運行確認OQOperation Qualification性能確認PQPerformance Qualification14/89計算機化系統(tǒng)驗證常見術(shù)語 2Common Glossary for Computerized System Validation 12名稱 縮寫Abbr.英文 可追溯矩陣TMTraceability Matrix驗證總結(jié)報告VSRValidation Summary Report國際制藥工程協(xié)會ISPEInternational Society Of Pharmaceutical Engineer

32、ing良好自動化生產(chǎn)實踐指南GAMPGood Automated Manufacturing Practice質(zhì)量管理系統(tǒng)QMSQuality Management System可編程邏輯控制器PLCProgrammable Logic Controller集散控制系統(tǒng)DCSDistributed Control System數(shù)據(jù)采集與監(jiān)視系統(tǒng)SCADASupervisory Control And Data Acquisition企業(yè)資源計劃ERPEnterprise Resource Planning實驗室信息管理系統(tǒng)LIMSLaboratory Information Managemen

33、t System生產(chǎn)執(zhí)行系統(tǒng)MESManufacturing Execution Systems樓宇管理系統(tǒng)BMSBuilding Management System環(huán)境監(jiān)視系統(tǒng)EMSEnvironment Monitoring System計算機系統(tǒng)驗證CSVComputer System Validation不間斷電源UPSUninterruptible Power Supply15/89新建計算機化系統(tǒng)驗證流程介紹Introduction to Validation Process of New Computerized System 第二部分 Part 2CSV經(jīng)典V-Model圖及其

34、總流程 CSV classic V-Model and general flow chart 流程逐一步驟的良好實踐 Good practices of process steps 16/89計算機化系統(tǒng)驗證生命周期V-Model V-Model of computerized system validation lifecycle17/89驗證生命周期文件架構(gòu) Lifecycle documentation framework 18/89計算機化系統(tǒng)驗證總流程General flow of computerized system validation 確認計算機化系統(tǒng) Computerize

35、d system definition初步系統(tǒng)評估確定系統(tǒng)影響，判定GxP系統(tǒng) Perform initial system assessment and determine system impacts, and GxP system供應商評估確定其能力及參與評估點 Perform supplier assessment and determine their capacity and involvement assessment points軟硬件分類評估確定其復雜性和新穎性 Perform hardware and software categorization assessment a

36、nd determine their complexity and novelty .結(jié)合供應商能力，系統(tǒng)復雜性和新穎性、GxP影響制定適宜V-Model Make an appropriate V-Model in conjunction with supplier capacity, system complexity and novelty and GxP impacts按照既定的V-Model實施確認 Perform verification as established in the V-Model19/89流程良好實踐 1-1 Process Good Practices 通過網(wǎng)絡(luò)

37、結(jié)構(gòu)圖，找到接口界面 “云圖”的方式劃分界定系統(tǒng) Define systems through network structure chart, and interface “cloud picture 確認計算機化系統(tǒng)Computerized system definition20/89流程良好實踐 1-2 Process Good Practices 1-2 確認計算機化系統(tǒng)Computerized system definitionWhen network architecture diagram is not available for no supplier performs sec

38、ondary development at the initial stage , the computerized system summary list is considered as the basis for defining systems.項目初期沒有供應商二次開發(fā)無法得到網(wǎng)絡(luò)架構(gòu)圖時，可考慮采用計算機化系統(tǒng)清單匯總作為界定劃分系統(tǒng)的依據(jù)21/89流程良好實踐 2 Process Good Practices 2 Select GxP critical systems through GxP risk assessment questions 通過GxP評估問題篩選出GxP關(guān)鍵系

39、統(tǒng) Perform initial risk assessment and determine GxP critical systems初步風險評估判定GxP關(guān)鍵系統(tǒng)Does the system generate, manipulate or control data supporting regulatory safety and efficacy submissions?系統(tǒng)是否生成、處理或控制用于支持法規(guī)安全性和功效提交文件的數(shù)據(jù)？Does the system control critical parameters and data in preclinical, clinical,

40、 development, or manufacturing?系統(tǒng)是否控制臨床前、臨床、開發(fā)或生產(chǎn)相關(guān)關(guān)鍵參數(shù)和數(shù)據(jù)？Does the system control or provide data or information for product release?系統(tǒng)是否控制或提供有關(guān)產(chǎn)品放行的數(shù)據(jù)或信息？Does the system control data or information required in case of product recall?系統(tǒng)是否控制與產(chǎn)品召回相關(guān)要求的數(shù)據(jù)或信息？系Does the system control adverse event or c

41、ompliant recording or reporting?統(tǒng)是否控制不良事件或投訴的記錄或報告？Does the system support pharmacovigilance? 系統(tǒng)是否支持藥物安全監(jiān)視？Critical systems are subject to validation, and non-critical systems are subject to GEP commissioning only. 關(guān)鍵系統(tǒng)做驗證，非關(guān)鍵系統(tǒng)GEP調(diào)試即可22/89流程良好實踐 3供應商評估確定其能力及參與平衡點對每一受GxP監(jiān)管的計算機化系統(tǒng)和服務(wù)的供應商進行正式的評估，來確認計算

42、機系統(tǒng)能夠以高標準滿足他們的技術(shù)、商業(yè)及法規(guī)要求，同時確認能夠充分利用供應商的知識、經(jīng)驗和文件。通過供應商審計來識別供應商QMS以及其能力水平方面的風險，被監(jiān)管公司對計算機系統(tǒng)和服務(wù)供應商的質(zhì)量和可靠性進行確認，要求有文件化的證據(jù)來證明該計算機系統(tǒng)能夠如所預期的持續(xù)運行，并確保軟件結(jié)構(gòu)和功能的完整性。23/89Process Good Practices 3Perform supplier assessment and determine their capacity and involvement balance pointFormal assessment is performed to

43、each supplier of computerized system and service under the regulation of GxP, to verify that the computerized system can meet their technical, commercial and regulatory requirements, and at the same time make the best use of suppliers knowledge, experience and documents. Risks of suppliers QMS and c

44、apacity are identified through a supplier audit. The company under the regulation verify the quality and reliability of supplier of computerized system and services, and documented evidence is required to prove the computerized system can run continuously as intended, and ensure the integrity of sof

45、tware structure and function. 24/89流程良好實踐 4-1軟硬件分類評估確定其復雜性和新穎性硬件分2類 軟件分4類通過識別軟硬件類別來識別復雜性和新穎性帶來的風險，從而確定出適宜的可增減周期策略25/89Process Good Practices 4-1Perform hardware and software categorization assessment and determine their complexity and novelty .Hardware is divided into two categories. Software is div

46、ided into four categories. Identify risks from complexity and novelty through identifying hardware and software categories, to determine proper extendable life cycle strategy. 26/89流程良好實踐 4-2 硬件類別類別典型方法1, 標準硬件部件通過文件記錄下生產(chǎn)廠家或供應商的詳情、序列號和版本號確認正確的安裝適用配置管理和變更控制2, 定制制造的硬件部件上述內(nèi)容再加上：設(shè)計說明驗收測試適用配置和變更控制27/89Pro

47、cess Good Practices 4-2 Hardware Categories CategoryCategoryTypical ApproachTypical Approach1. Standard Hardware 1. Standard Hardware ComponentsComponentsDocument manufacturer or supplier detail, serial number and Document manufacturer or supplier detail, serial number and version number version num

48、ber Correct installation to be verified Correct installation to be verified Configuration Management and Change control applyConfiguration Management and Change control apply2. Custom Built 2. Custom Built Hardware ComponentsHardware ComponentsThe above plus: The above plus: Design specificationDesi

49、gn specificationAcceptance testingAcceptance testingConfiguration and Change control apply Configuration and Change control apply 28/89流程良好實踐 4-3 硬件類別硬件類別第二類定制制造部件第一類標準部件29/89Process Good Practices 4-3 Hardware Categories Hardware CategoryCategory 2Custom Built Hardware ComponentsCategory 1Standard

50、Hardware Components30/89流程良好實踐 4-4 軟件類別31/89Process Good Practices 4-4 Software Categories TypeGAMP5GAMP51Operating systemInfrastructure SoftwareInfrastructure Software2Firmware Out of use3Standard software packageNon-configured4Configured software packageConfigured 5Custom(reserved)softwareCustom32

51、/89流程良好實踐 4-5 軟件類別類別說明典型示例典型方法1, 基礎(chǔ)設(shè)施軟件分層式軟件用于管理操作環(huán)境的軟件操作系統(tǒng)數(shù)據(jù)庫引擎中間件編程語言電子制表軟件版本控制給你工具網(wǎng)絡(luò)監(jiān)控工具記錄版本號，按照所批準的安裝規(guī)程驗證正確的安裝方式。3, 非配置軟件可以輸入并儲存運行參數(shù)，但是并不能對軟件進行配置以適合業(yè)務(wù)流程基于固件的應用程序COTS軟件簡化的生命周期法URS 用戶需求說明基于風險的供應商審計/評估記錄版本號，驗證正確的安裝方式基于風險進行測試有用于維持系統(tǒng)符合性的規(guī)程33/89Process Good Practices 4-5 Software Categories CategoryCa

52、tegoryDescriptionDescriptionTypical examplesTypical examplesTypical ApproachTypical Approach1. 1. Infrastructure Infrastructure SoftwareSoftwareLayered softwareLayered softwareSoftware used to Software used to manage the operating manage the operating environmentenvironmentOperating systemsOperating

53、 systemsDatabase enginesDatabase enginesMiddlewareMiddlewareProgramming languagesProgramming languagesSpreadsheetsSpreadsheetsVersion control toolsVersion control toolsNetwork monitoring toolsNetwork monitoring toolsRecord version number, verify correct Record version number, verify correct installa

54、tion by following approved installation by following approved installation procedureinstallation procedure3. Non-3. Non-configuredconfiguredRuntime parameters Runtime parameters maybe entered and maybe entered and stored, but the software stored, but the software can not be configured to can not be

55、configured to suit the business processsuit the business processFirmware based applications Firmware based applications COTs software COTSCOTs software COTSAbbreviated Life cycle approachAbbreviated Life cycle approachURSURSRisk based approach to supplier Risk based approach to supplier assessmentas

56、sessmentRecord version number, verify correct Record version number, verify correct installationinstallationRisk based testRisk based testProcedure in place for maintaining Procedure in place for maintaining compliancecompliance34/89流程良好實踐 4-6 軟件類別類別說明典型示例典型方法4, 可配置這種軟件通常非常復雜，可以由用戶來進行配置以滿足用戶具體業(yè)務(wù)流程的特

57、殊要求。這種軟件的編碼不能更改。SCADADCSBMSHMILIMSERPClinical trail monitoring生命周期法基于風險的供應商審計/評估供應商的質(zhì)量管理系統(tǒng)記錄版本號，驗證正確的安裝方式在測試環(huán)境中根據(jù)風險進行測試在業(yè)務(wù)流程中根據(jù)風險進行測試具有維持符合性的規(guī)程5, 定制定制設(shè)計和編碼以適于業(yè)務(wù)流程的軟件內(nèi)部和外部開發(fā)的IT應用程序內(nèi)部和外部開發(fā)的工藝控制應用程序定制功能邏輯定制固件電子制表軟件（宏）與第4類相同，再加上更嚴格的公用設(shè)施評估，包括進行供應商審計完整的生命周期設(shè)計和源代碼回顧35/89Process Good Practices 4-6 Software

58、Categories CategoryCategoryDescriptionDescriptionTypical examplesTypical examplesTypical ApproachTypical Approach4.4.Configured Configured Software, often Software, often very complex, very complex, that can be that can be configured by configured by the user to meet the user to meet the specific th

59、e specific needs of the needs of the users business users business process. process. Software code Software code is not altered.is not altered.DAQ systemsDAQ systemsSCADASCADADCSDCSBMSBMSHMIHMILIMSLIMSERPERPClinical trail monitoringClinical trail monitoringLife cycle approachLife cycle approachRisk

60、based approach to supplier assessmentRisk based approach to supplier assessmentSupplier QMSSupplier QMSRecord version number, verify correct installationRecord version number, verify correct installationRisk based testing in a test environmentRisk based testing in a test environmentRisk based testin