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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GBZ42344-2023: Verify guidance for computerized system of pharmaceutical machinery (equipment) Status: Valid
Basic dataStandard ID: GB/Z 42344-2023 (GB/Z42344-2023)Description (Translated English): Verify guidance for computerized system of pharmaceutical machinery (equipment) Sector / Industry: National Standard Classification of Chinese Standard: C90 Classification of International Standard: 11.120.30 Word Count Estimation: 19,195 Date of Issue: 2023-03-17 Date of Implementation: 2023-10-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GBZ42344-2023: Verify guidance for computerized system of pharmaceutical machinery (equipment)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS11:120:30 CCSC90 National Standardization Guidance Technical Document of the People's Republic of China Guidelines for Validation of Computerized Systems for Pharmaceutical Machinery (Equipment) machinery (equipment) 2023-10-01 implementation State Administration for Market Regulation Released by the National Standardization Management Committee table of contentsPreface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General 2 5 Verification process 3 6 System Verification Scheme 5 7 Personnel training 10 8 Verification document management 10 Appendix A (Informative) Risk Assessment Example 12 Appendix B (Informative) Document List Example 14 Reference 15forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed and managed by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356): This document was drafted by: Shandong Xinhua Medical Devices Co:, Ltd:, Zhejiang University, Zhejiang Canaan Technology Co:, Ltd:, Truking Technology Co:, Ltd: The main drafters of this document: Zhang Qingjie, Cui Yuanfu, Liu Xuesong, Wu Wutong, Yang Wenlu, Li Yerui, Xie Zhongze, Tan Liang, Xi Guangyao, Chen Yong, Long Tao, Liu Zhi, Ji Kunpeng, Luo Xiang, Fang Huan, Huang Shaoqing, Ma Guanglei, Li Xinhua, Wang Xuyong, Wang Dong, Ding Hongyong, Pan Xuhui, Han Yao, Zhang Licun, Wang Hongmin: Guidelines for Validation of Computerized Systems for Pharmaceutical Machinery (Equipment)1 ScopeThis document provides guidelines for the verification of pharmaceutical machinery (equipment) computerized systems, including general principles, verification procedures, system verification schemes, Personnel training and validation document management: This document is applicable to the verification of pharmaceutical machinery (equipment) computerized systems, pharmaceutical manufacturers, pharmaceutical equipment manufacturers, third-party Certification agencies can refer to it:2 Normative referencesThis document has no normative references:3 Terms and DefinitionsThe following terms and definitions apply to this document: 3:1 Production equipment that completes and assists in the completion of the pharmaceutical process: [Source: GB/T 15692-2008, 2:1] 3:2 It is a system composed of a series of hardware and software to meet the specific functions of pharmaceutical machinery (equipment) in the quality management process of pharmaceutical production: Note: Hereinafter referred to as the system: 3:3 validation report validationreport Documents for reviewing, reviewing and evaluating the verification scheme and the results of completed verification tests, missing items and deviations: [Source: GB/T 28671-2012, 3:9] 3:4 Electronic signature electronic signatures Electronic data is the data contained in electronic form and attached to identify the signatory and to indicate that the signatory approves the content: 3:5 electronic data electronic data Information generated, sent, received or stored by electronic, optical, magnetic or similar means: 3:6 The whole life cycle of the system lifecycleofsystem The process of a computerized system from the presentation of user requirements to its end of use: Note: The full life cycle of the system includes design, standard setting, programming, testing, installation, operation, maintenance and other stages, hereinafter referred to as the life cycle: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GBZ42344-2023_English be delivered?Answer: Upon your order, we will start to translate GBZ42344-2023_English as soon as possible, and keep you informed of the progress. 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