▍来源：GMP办公室 声明：转载只是为了学习，涉及侵权，立即删除。
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适当程度的挑战性测试（如边界，范围，限制，无效输入测试），以确认系统可以正确地处理不正确的输入或不正确的使用。
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verification that alarms are raised based upon alarm conditions;
确认在警报条件下能触发报警
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flags are raised to signal invalid or altered data.
无效信号或被修改的数据可以被标记
12. STANDARD OPERATING PROCEDURES AND TRAINING
标准操作规程和培训
12.1. Prior to the conduct of the performance qualification (PQ) and user acceptance testing (UAT), and prior to the release of the computerized system, there should be adequate written procedures and documents and training programmes created defining system use and control. These may include vendor-supplied user manuals as well as SOPs and training programs developed in-house.
在性能确认（PQ）和用户验收测试（UAT）开始前，以及在计算机化系统放行之前，应建立充分的定义系统使用和控制的书面规程和文件以及培训程序。包括供应商提供的用户手册以及企业 SOP 和培训程序。
12.2. Procedures and training programs that should be developed include, but are not necessarily limited to:
应起草的规程和培训程序包括，但不限于：
system use procedures that address:
系统使用规程，明确：
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routine operation and use of the system in the intended business process(es),
系统在既定业务流程内的日常操作和使用
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review of the electronic data and associated metadata (such as audit trails) and how the source electronic records will be reconciled with printouts, if any,
电子数据及相关元数据（如审计追踪）的审核，以及如打印，怎样对比原始电子记录和打印的纸质记录
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mechanisms for signing electronic data,
签署电子数据的机制
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system training requirements prior to being granted system access;
在授予系统访问权限之前的系统培训要求
system administration procedures that address:
系统管理规程，明确：
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granting and disabling user access and maintaining security controls,
用户访问和维护安全控制的授权和禁用
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backup/restore,
备份/恢复
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archival/retrieval,
归档/检索
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disaster recovery and business continuity,
灾难恢复和业务连续性
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change management,
变更管理
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incident and problem management,
事件和问题管理
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system maintenance.
系统维护
13. PERFORMANCE QUALIFICATION AND USER ACCEPTANCE TESTING
性能确认和用户验收测试
13.1. PQ, that includes UAT, should be conducted to verify the intended system use and administration defined in the URS and design qualification (DQ), or equivalent document.
应执行 PQ，包括 UAT，以确认 URS 和设计确认（DQ），或其它同等文件中规定的系统预期用途和管理。
13.2. The PQ should be conducted in the live environment or in a test environment that is equivalent to the live environment in terms of overall software and hardware configuration.
PQ 应在使用环境下，或等同于使用环境的测试环境（包括整体软件和硬件配置方面）下执行。
13.3. PQtestingshouldalsoinclude,asapplicable,anappropriatedegreeof stress/load/volume testing based upon the anticipated system use and performance requirements in the production environment.
PQ 测试应包括，如适用，根据系统预期用途和在使用环境下的性能要求进行适当的压力/负载/容量测试。
13.4. In addition, an appropriate degree of end-to-end or regression testing of the system should be conducted to verify the system performs reliably when system components are integrated in the fully-configured system deployed in the production environment.
另外，应执行适当程度的系统的端到端或回归测试，以确认系统组件在使用环境集成为一个完全配置的系统后，系统性能可靠。
13.5. UAT should be conducted by system users to verify the adequacy of system, use of SOPs and training programs. The UAT should include verification of the ability to generate and process only valid data within the computerized system, including the ability to efficiently review electronic data and metadata, such as audit trails.
系统用户应进行 UAT 测试以确认系统、SOP 使用和培训项目的充分性。UAT 应包括，确认在计算机化系统内，生成和处理数据有效的能力，包括能够有效地审核电子数据和元数据的能力，如审计追踪。
Legacy systems
遗留系统
13.6. The continued use of a legacy system should be justified by demonstrating the system continues to be relevant to the GMP process being supported and by ensuring adequate validation of the system has been performed.
遗留系统的继续使用应经过论证，证明系统继续与所支持的 GMP 流程相关，并确保实施了充分的系统验证。
13.7. The validation approach to be taken should aim at providing data and information to support the retrospective documentation of the system as well as requalification evidence.
所采取的验证方法应能提供用于支持系统回顾性文件以及再确认证据的数据和信息。
13.8. A risk assessment should be undertaken to determine the criticality of the system to the process or operation being supported and a gap analysis should identify the level of completeness of existing qualification documentation (e.g. URS, IQ/OQ/PQ, SOPs) and state of system control, operation and maintenance.
应进行风险评估，确定系统对于其所支持的流程或操作的关键性，并进行差距分析识别现有确认文件（如 URS,IQ/OQ/PQ,SOP）的完整程度，以及系统控制、操作和维护的说明。
13.9. For legacy systems, because of their age and unique characteristics, the system development documentation and records appropriate for validation may not be available. Nevertheless, the strategy should be consistent with validation principles where assurance is established, based on compilation and formal review of the history of use, maintenance, error report and change control system records. These activities should be based on documented URS. If historical data do not encompass the current range of operating parameters, or if there have been significant changes between past and current practices, then retrospective data would not of itself support validation of the current system.
对于遗留系统，由于其年限和独特的特性，可能不具备适用于验证的开发文件和记录。然而，验证策略应在基于系统历史使用、维护、错误报告和变更控制系统记录的梳理和正式审核，与质量保证验证原则一致。这些活动应基于书面的 URS。如果历史数据不能够覆盖运行参数的现行范围，或者过去和现行的状态之间曾有过重大变更的，那么回顾性数据不能用于支持现行系统的验证。
13.10. The validation exercise should demonstrate that user requirements and system description have been appropriately established as well as provide evidence that the system has been qualified and accepted and that GXP requirements are met.
验证活动应证明已恰当地制定用户需求和系统描述，并提供系统经确认和接受，符合 GXP 要求的证据。
13.11. System retirement should be considered as a system life-cycle phase. It should be planned, risk-based and documented. If migration or archiving of GMP-relevant data (4) is necessary, the process must be documented.
系统退役应作为系统生命周期的一个阶段进行考察。系统退役应有计划，基于风险和书面化。如果需要迁移或归档 GMP 相关数据，那么该过程应被记录。
13.12. Where electronic data are transferred from one system to another it should be demonstrated that data are not altered during the migration process. Conversion of data to a different format should be considered as data migration. Where data are transferred to another medium, data must be verified as an exact copy prior to any destruction of the original data.
如果电子数据由一个系统转移到另一个，那么应证明数据在迁移过程中没有被改变。将数据转换为不同格式应被视为数据迁移。当数据转移到另一个介质中，在销毁原始数据之前，必须确认转移后的数据为真实副本。
13.13. Data migration efforts may vary greatly in complexity and measures to ensure appropriate transfer of data should be commensurate to identified risks. Migrated data should remain usable and should retain its content and meaning. The value and/or meaning of and links between a system audit trail and electronic signatures should be ensured in a migration process.
数据迁移的难易程度根据系统复杂性而大不相同。用于保证数据正确转移的措施应与所识别的风险相匹配。迁移后的数据应保持其可用性，并保留其内容和含义。迁移过程应保证系统审计追踪和电子签名与原数值和/或含义之间的链接。
14. SYSTEM OPERATION AND MAINTENANCE
系统操作和维护
Security and access control
安全和访问控制
14.1. Manufacturers should have systems and procedures in place to ensure security of data integrity and access control to computerized systems.
生产商应具备系统和程序，保证完整数据的安全性和计算机化系统的访问控制。
14.2. Suitable security measures should be in place to prevent unauthorized entry or manipulation or deletion of data through both the application software as well as in operating system environments in which data may be stored or transmitted. Data should be entered or amended only by persons authorized to do so.
应制定适当的控制措施防止对数据未经授权的进入或篡改或删除，不管是通过软件本身还是储存或传输数据的操作系统。数据只能由授权人员输入或修正。
14.3. The activity of entering data, changing or amending incorrect entries and creating backups should be done in accordance with SOPs.
输入数据、改变或修改错误输入，以及创建备份等活动应按照 SOP 进行。
14.4. Security should extend to devices used to store programs. Access to these devices should be controlled.
安全措施应延伸至储存程序的设备。应控制对这些设备的访问。
14.5. Procedures for review of audit trails and when necessary metadata should define the frequency, roles and responsibilities, and nature of these reviews.
审计追踪审核和适用情形下元数据审核的规程，应规定审核活动的频率、角色和职责，以及审核的性质。
14.6. Actions, performance of the system and acquisition of data should be traceable and identify the persons who made entries and or changes, approved decisions or performed other critical steps in system use or control.
系统的活动、性能和数据的采集应可追溯，并识别那些在系统使用和控制中进行输入或修改，批准决定或实施其它关键步骤的人员。
14.7. Details on user profiles, access rights to systems, networks, servers, computerized systems and software should be documented and an up-to-date list on the individual user rights for the software, individual computer systems and networks should be maintained and subjected to change control. The level of detail should be sufficient to enable computer system validation personnel, information technology (IT) personnel/any external auditor/inspector to ascertain that security features of the system and of software used to obtain and process critical data cannot be circumvented.
应记录关于用户配置，系统访问权限，网络，服务器，计算机化系统和软件的详细情况，并维护一份实时更新的权限清单记录软件、个人计算机系统和网络的用户权限，并遵循变更控制。该清单应足够详细，以帮助计算机系统验证人员、信息技术（IT）人员/任何外部审计人员/检查人员可以确定用于获取和处理关键数据的系统和软件具备安全的特性。
14.8. All GMP computerized systems, either stand-alone or in a network, should have a system commensurate to identified risks for monitoring through an audit trail events that are relevant. These events should include all elements that need to be monitored to ensure that the integrity (5) of the data could not have been compromised, such as but not limited to, changes in data,deletionofdata,dates,times,backups,archives,changesinuseraccessrights, addition/deletion of users and logins. In accordance with WHO guidance on good data and record management practices (5). The configuration and archival of these audit trails should be documented and also be subjected to change control. These audit trails should be accurate, consistent,secure and available through out the retention period and their generation appropriately qualified.
所有 GMP 计算机化系统，不管是单机还是网络版，应具备一个与所识别的风险相适应的审计追踪事件相关的监测系统。被追踪的事件应包括所有需要被监控的要素，以确保数据完整性不受到危害，例如（但不局限于），数据更改，数据删除，日期，时间，备份，归档，用户访问权限变更，用户和登陆账号的增加/删除。为符合 WHO 《数据和记录管理规范》，应记录这些审计追踪记录的配置和归档，并遵循变更控制。这些审计追踪记录应准确、一致、安全并在整个保存期间可用，审计追踪的生成应经过确认。
Operation and maintenance
操作和维护
14.9. Entry of data into a computerized system should be verified by an independent authorized person and locked before release for routine use.
将数据输入到一个计算机化系统的过程应由一个独立的经授权的人员确认，并在放行用于日常使用前锁定。
14.10. Validated computerized systems should be maintained in a validated state once released to the GXP production environment.
已验证的计算机化系统应在放行至 GXP 生产环境后保持验证状态。
14.11. There should be written procedures governing system operation and maintenance, including, for example:
应具备书面规程管理系统操作和维护，包括：
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performance monitoring;
性能监测
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change management and configuration management;
变更管理和配置管理
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problem/incident management;
问题/事件管理
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program and data security;
程序和数据安全
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program and data backup/restore and archival/retrieval;
程序和数据备份/恢复和归档/检索
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system administration and maintenance;
系统管理和维护
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data flow and data life cycle;
数据流和数据生命周期
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system use and review of electronic data and metadata (such as audit trails);
系统使用和电子数据及元数据（如审计追踪）审核
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personnel training;
人员培训
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disaster recovery and business continuity;
灾难恢复和业务连续性
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availability of spare parts and technical support;
备件供应情况和技术支持
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periodic re-evaluation.
定期再评价
Periodic review
周期性回顾
14.12. Computerized systems should be periodically reviewed to determine whether the system remains in a validated state or whether there is a need for revalidation. The scope and extent of the revalidation should be determined using a risk-based approach. The review should at least cover:
应定期回顾计算机化系统，以确定系统是否保持在一个已验证的状态或者是否需要再验证。再验证的范围和程度应使用基于风险的方法确定。回顾应至少覆盖：
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review of changes;
变更回顾
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review of deviations;
偏差回顾
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review of incidents/ events;
事件回顾
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systems documentation;
系统文件
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procedures;
规程
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training;
培训
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effectiveness of corrective and preventive action (CAPA).
整改预防措施 CAPA 的有效性
14.13. CAPA should be taken where indicated as a result of the periodic review.
当周期性回顾的结论指明需要 CAPA 时，应启动 CAPA。
14.14. Automatic or live updates should be subject to review prior to becoming effective.
自动升级或在线升级应在执行前进行审核。
15. SYSTEM RETIREMENT
系统退役
15.1. Once the computerized system or components are no longer needed, the system or components should be retired and decommissioned in accordance with established authorized procedures including a change control procedure and a formal plan for retirement.
一旦不再需要计算机化系统或其组件时，系统或组件应按照已建立经批准的程序进行退役。批准的规程包括变更控制程序和一份正式的退役计划。
15.2. Records should be in a readable form and in a manner that preserves the content and meaning of the source electronic records throughout the required records retention period.
尽管退役，仍应保持在整个所要求的记录保存期间，确保记录的可读性，并保持原电子记录的内容和含义。
15.3. The outcome of the retirement activities, including traceability of the data and computerized systems, should be presented in a report.
退役活动的结果，包括数据和计算机化系统的可追溯性，应呈现在报告中。