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[其他] WHO《计算机化系统验证指南》-2018

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发表于 2018-11-30 08:53:50 | 显示全部楼层 |阅读模式
WHO今年发布了验证指南-附录5 计算机化系统验证(征求意见稿),相比于其他机构发布的《计算机化系统验证指南》WHO发布的这版要求更加严格,内容更加具体。该指南共16章,涵盖计算机化系统验证方案和报告供应商管理用户需求规范系统设计和配置规范设计确认构建和项目实施安装确认运行确认标准操作规程和培训性能确认系统维护系统退役等内容,全文翻译如下:
4.  COMPUTERIZED SYSTEM VALIDATION PROTOCOLS AND REPORTS
计算机化系统验证方案和报告

4.1. A computerized system needs to be validated according to an approved protocol and final report including results and conclusions prior to routine use.
计算机化系统需要根据一份批准的方案进行验证并在日常使用前报告验证结果和结论。

Validation protocol
验证方案

4.2.  Validation should be executed in accordance with the validation protocol and applicable written procedures.
验证应根据验证方案和适当的书面规程执行。

4.3. A validation protocol should define the objectives, the validation strategy, including roles and responsibilities and documentation and activities to be performed. The protocol should at least cover the scope, risk management approach, the specification, testing, review and release of the computerized system for GMP use.
验证方案应规定目的,验证策略,包括角色和职责以及将要执行的文件和活动。方案应至少包括范围、风险管理方法、计算机化系统的标准、测试,审核与放行。

4.4. The  validation  protocol  should  be  tailored  to  the  system  type,  impact,  risks  and requirements applicable to the system for which it governs validation activities.
验证方案应与系统的类型、影响、风险和系统所适用的要求相适应,从而决定验证活动。

Validation report
验证报告

4.5.  A validation report should be prepared, summarizing system validation activities.
应起草验证报告,总结系统验证活动。

4.6. It should make reference to the protocol and outline the validation process, and include an evaluation and conclusion on results. Deviations from the validation protocol and applicable written  procedures  should  be  described,  investigated,  assessed  and  justification  for  their acceptance or rejection should be documented.
验证报告应索与验证方案相关联,并概述验证过程,并包括对所获得结果的评价和结论。应描述、调查、和评估任何不符合验证方案和相应书面规程的偏差,并记录可接受或不可接受的论证过程。

4.7. Results should be recorded, reviewed, analyzed and compared against the predetermined acceptance  criteria.  All  critical  and  major  test  discrepancies  that  occurred  during  the verification/validation  testing,  should  be  investigated  and  if  accepted  they  should  be appropriately justified.
应记录、审核、分析结果,并与预定可接受标准进行比较。所有在验证/确认测试过程中发生的关键和主要的测试偏差都应被调查,如接受,应进行适当的论证。

4.8. The conclusion of the report should state whether or not the outcome of the validation was considered  successful  and  should  make  recommendations  for  future  monitoring  where applicable. The report should be approved after appropriately addressing any issue identified during validation and the system should then be released for GMP use.
报告应给出验证结果是否视为成功的结论,并在适用时,应给出针对将来监测的建议。报告应在适当地解决验证中发现的问题后被批准,然后放行至GMP用途。

5.  VENDOR MANAGEMENT
供应商管理

5.1. When third parties (e.g. vendors, service providers) are used, e.g. to provide, install, configure, validate, maintain, modify or retain a computerized system or related service or for data processing or system components, including cloud-based systems, an evaluation of the vendor-supplied system or service and the vendor’s quality systems should be conducted and recorded.  The  scope  and  depth  of  this  evaluation  should  be  based  upon  risk  management principles.
当使用第三方(如供应商,服务提供商),如供应、安装、配置、验证、维护、修改或保存计算机化系统或相关服务或用于数据处理或系统组件,包括云系统,应对供应商的供应体系或服务及其质量体系进行评估并记录。该评估的范围和程度应基于风险管理原则。

5.2. The competence and reliability of a vendor are key factors when selecting a product and/or service provider and vendor management is an on-going process that requires periodic assessment  and  review.  Vendor  evaluation  activities  may  include  but  are  not  limited  to: completion of a quality related questionnaire by the vendor; gathering of vendor documentation related to system development, testing and maintenance includingvendor procedures, specifications, system architecture diagrams, test evidence, release notes and other relevant vendor documentation; an on-site audit of the vendor’s facilities should be conducted to evaluate the vendor’s system life-cycle control procedures, practices and documentation.
在选择一个产品和/或服务的供应商时,供应商的能力和可靠性是关键要素,并且,供应商管理是一个持续的过程,需要定期评估和回顾。供应商评估活动包括但不局限于:由供应商填写一份质量相关的问卷,收集与系统开发、测试和维护相关的供应商资料,包括供应商规程、标准、系统架构图、测试证据、放行说明和其它相关供应商文件,应实施对供应商工厂的现场审计以评估供应商系统生命周期控制程序,实践和文件。

5.3.  A contract should be in place between the manufacturer and the vendor and/or the service provider defining the roles and responsibilities and quality procedures for both parties, throughout the system life cycle. The contract acceptor should not pass to a third party any of the work entrusted to her/him under the contract without the manufacturer’s prior evaluation and approval of the arrangements.
药品生产企业应与供应商和/或服务提供商签订协议,规定整个系统生命周期内双方的角色和职责,以及质量程序。在药品生产企业预先评估和批准之前,合约受托方不得将委托给他/她的任何工作转交给第三方。

6.  REQUIREMENTS SPECIFICATIONS
需求规范

6.1. Requirements  specifications  should  be  written  to  document  user  requirements  and functional or operational requirements and performance requirements. Requirements may be documented in separate user requirements specifications (URS) and functional requirements specifications (FRS) documents or in a combined document.
应编写需求规范记录用户需求和功能或操作和性能的需求。各类需求可以记录在独立的用户需求规范(URS)和功能需求规范(FRS)中,也可以合并在一份文件中。

User requirements specifications
用户需求规范

6.2. The authorized URS document, or equivalent, should describe the intended uses of the proposed computerized system and should define critical data and data life-cycle controls that will assure consistent and reliable data throughout the processes by which data is created, processed, transmitted, reviewed, reported, retained and retrieved and eventually disposed.
批准的 URS 文件,或同等文件,应描述目标计算机化系统的预期用途,并应识别关键数据和数据生命周期控制措施,用于保证数据在产生、处理、传输、审核、报告、存储和检索以及最终处置的过程中的一致性和可靠性。

6.3. The URS should be written in a way to ensure that the data will meet regulatory requirements such as the WHO Guidance on good data and record management practices (5).
URS 的编写应符合法规要求,如 WHO 良好数据和记录管理实践指南。

6.4.  Other aspects that should be specified include, but are not limited to, those related to:
其它应指出的方面,包括但不局限于如下:

·
the data to be entered, processed, reported, stored and retrieved by the system, including any master data and other data considered to be the most critical to system control and data output;
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将要由系统输入、处理、报告、储存和检索的数据,包括所有主数据和其它对系统控制和数据输出最为关键的数据。
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·
the flow of data including that of the business process(es) in which the system will be used as well as the physical transfer of the data from the system to other systems or network  components.  Documentation  of  data  flows  and  data  process  maps  are recommended to facilitate the assessment and mitigation and control of data integrity risks across the actual, intended data process(es);
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数据流,包括系统将要使用的业务流程,以及数据从一个系统到另一个系统或网络组件的物理转移。建议有数据流和数据流程图文件,以帮助在实际、预定数据流程下评估、降低和控制数据可靠性风险。
·
·
networks and operating system environments that support the data flows;
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支持数据流的网络和操作系统环境。
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how the system interfaces with other systems;
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系统怎样与其它系统交互。
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the operating program;
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操作程序
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synchronization and security controls of time/date stamps;
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时间/日期戳的同步和安全控制。
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controls of both the application software as well as operating systems to assure system access only to authorized persons;
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对应用程序和操作系统的访问控制,保证仅限于授权用户。
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controls to ensure that data will be attributable to unique individuals (for example, to prohibit use of shared or generic login credentials);
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保证数据可追溯至个人的控制措施(例如,禁止使用共用或通用的登陆凭证)。
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controls to ensure that data is legibly and contemporaneously recorded to durable (“permanent”) media at the time of each step and event and controls that enforce the sequencing of each step and event (for example, controls that prevent alteration of data in temporary memory in a manner that would not be documented);
·
控制措施以保证数据各个步骤和事件发生时都能清晰地记录到持久的(永久的)介质上,以及确保对各个步骤和事件的顺序(例如,防止对储存在临时内存上的数据以一种无法记录的方式被修改)。
·
·
controls that assure that all steps that create, modify or delete electronic data will be recorded  in  independent,  computer-generated  audit  trails  or  other  metadata  or alternate documents that record the “what” (e.g. original entry), “who” (e.g. user identification), “when” (e.g. time/date stamp) and “why” (e.g. reason) of the action;
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保证所有创建、修改、或删除电子数据的步骤都将被记录于独立的、计算机生成的审计追踪,或其它元数据,或替代的记录,明确该活动的什么(如原始输入),(如用户 ID),何时(如时间/日期戳),以及为什么(如原因)。
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backups and the ability to restore the system and data from backups;
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备份以及从备份恢复系统和数据的能力。
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the ability to archive and retrieve the electronic data in a manner that assures that the archive copy preserves the full content of the original electronic data set, including all metadata needed to fully reconstruct the GMP activity. The archive copy should also preserve the meaning of the original electronic data set;
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归档和检索电子数据的能力, 以确保归档副本保留原始电子数据集的全部内容, 包括充分重建GMP活动所需的所有元数据。归档副本还应保留原始电子数据集的含义;
·
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input/output  checks,  including  implementation  of  procedures  for  the  review  of original electronic data and metadata, such as audit trails;
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输入/输出检查,包括实施审核原始电子数据和元数据的程序,如审计追踪。
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controls for electronic signatures;
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电子签名的控制措施。
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alarms and flags that indicate alarm conditions and invalid and altered data in order to facilitate detection and review of these events;
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用以提示报警条件、失效和数据修改的报警和标志,以帮助发现和审核这些事件。
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system documentation, including system specifications documents, user manuals and procedures for system use, data review and system administration;
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系统文件,包括系统标准文件,用户手册和系统使用,数据审核和系统管理的规程。
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system capacity and volume requirements based upon the predicted system usage and performance requirements;
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根据预期的系统使用和性能要求,提出系统能力和容量需求。
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performance monitoring of the system;
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系统性能监测。
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controls for orderly system shutdown and recovery;
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确保系统的关闭和恢复有序进行的控制措施。
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business continuity.
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业务连续性。
·

6.5. The extent and detail of the requirements should be commensurate with the operational risk and the complexity of the computerized system. User requirements should be specific and be phrased in a way to support their testing or verification within the computerized system’s context.
需求的范围和详细程度应与其运行风险和计算机化系统复杂程度相匹配。用户需求应具体,并以一种可以在计算机化系统语境下支持测试或确认的方式进行措辞。

Functional specifications
功能规范

6.6. Functional  specifications  should  describe  in  detail  the  functions,  performances  and interfaces of the computerized system based upon technical requirements needed to satisfy user requirements.
功能规范应基于所需的技术要求详细说明计算机化系统的功能,性能和接口,以满足用户需求。

6.7. The functional specifications provide a basis for the system design and configuration specifications.  Functional  specifications  should  consider  requirements  for  operation  of  the computerized system in the intended computing environment, such as functions provided by vendor-supplied software as well as functions required for user business processes that are not met by commercial off-the-shelf software (COTS) functionality and default configurations  that will require custom code development. Network infrastructure requirements should also be taken into account. Each described function should be verifiable.
功能规范为系统设计和配置规范提供了基础。功能规范应考虑计算机化系统在预期的计算机环境中运行所需的要求,如由供应商提供功能的软件,以及用户业务流程所需的功能无法通过商用现成软件和默认配置满足,需要定制化代码开发的软件。网络基础架构需求也应纳入考虑范围。每个所描述的功能均应可确认。

6.8. Personnel access roles that provide the ability and/or authorization to write, alter or access programs should be defined and qualified. There should be appropriate segregation of roles  between  personnel  responsible  for  the  business  process  and  personnel  for  system administration and maintenance.
应规定并确认具备写入、修改或访问程序的能力和/或授权的人员访问角色。应适当划分负责业务流程的人员,和负责系统管理和维护的人员的角色。

7.  SYSTEM DESIGN AND CONFIGURATION SPECIFICATIONS
系统设计和配置规范

7.1.  System design and configuration specifications should be developed based on user and functional requirements. Specification of design parameters and configuration settings (separate or combined) should ensure data integrity and compliance with the WHO guidance on good data and record management practices (5).
应基于用户和功能需求规范起草系统设计和配置规范。设计参数和配置设置的标准(单独的或整合的)应保证数据可靠性并符合 WHO 良好的数据和记录管理实践指南。

7.2. System  design  and  configuration  specifications  should  provide  a  high-level  system description as well as an overview of the system physical and logical architecture and should map out the system business process and relevant work flows and data flows if these have not already been documented in other requirements specifications documents.
系统设计和配置规范应提供一个高水平的系统描述以及系统物理和逻辑架构的概述,并应描绘出系统业务流程和相关工作流和数据流,如这些内容还没有在其它需求规范文件中记录。

7.3. The system design and configuration specifications may include, as applicable, a software design  specification  in  case  of  code  development  and  configuration  specifications  of  the software application parameters, such as security profiles, audit trail configuration, data libraries and other configurable elements.
系统设计和配置规范应包括,如适用,对于存在代码开发的情况,软件设计规范;软件应用程序参数的配置标准,如安全权限,审计追踪配置,数据库和其它配置要素。

7.4. In addition, the system design and configuration specifications may also include, based upon risk, the hardware  design  and  its  configuration specifications as  well  as that of  any supporting network infrastructure.
另外,系统和配置规范应根据风险包括:硬件设计及其配置规范,以及所有支持性网络架构的设计和配置规范。

7.5. System  design  and  configuration  specifications  should  include  secure,  protected, independent computer-generated audit trails to track configuration changes to critical  settings in the system.
系统设计和配置规范应包括安全的、受保护的、计算机独立生成的审计追踪,以追踪系统关键设置的配置变更。

8.  DESIGN QUALIFICATION
设计确认

8.1. A  design  review  should  be  conducted  to  verify  that  the  proposed  design  and configuration of the system is suitable for its intended purpose and will meet all applicable user and functional requirements specifications.
应进行设计审查以确认所提出的系统设计和配置适用于其预期用户并符合所有适用的用户和功能需求规范。

8.2. It may include a review of vendor documentation, if applicable, and verification that requirements specifications are traceable to proposed design and configuration specifications.
设计审查可以包括对供应商文件的审查(如适用),并确认可以追溯到所提出的设计和配置规范。

9.  BUILD AND PROJECT IMPLEMENTATION
构建和项目实施

9.1. Once the system requirements and the system design and configuration are specified and verified, where applicable, system development activities may begin. The development activities may occur as a dedicated phase following completion of specification of system requirements, design  and  configuration.  Alternatively,  development  activities  may  occur  iteratively  as requirements  are  specified  and  verified  (such  as  when  prototyping  or  rapid-development methodologies are employed).
一旦系统需求及系统设计和配置被明确和确认,系统开发活动就可以开始(如适用)。开发活动可以作为一个独立的阶段,在完成系统的需求、设计和配置规范后执行。或者,开发活动也可以在需求被明确和确认过程中反复进行(如,采用原型法或快速开发方法)。

Vendor-supplied systems
供应商提供的系统

9.2. For vendor-supplied systems, development controls for the vendor-supplied portion of the  computerized  system  should  be  assessed  during  the  vendor  evaluation  or  supplier qualification. For vendor-supplied systems that include custom components (such as custom- coded interfaces or custom report tools) and/or require configuration (such as configuration of securityprofilesinthesoftwareorconfigurationofthehardwarewithinthe network infrastructure),  the  system  should  be  developed  under  an  appropriate  documented  quality management system.
对于供应商提供的系统,应在供应商评估或确认阶段,评估由供应商提供的计算机化系统的开发过程控制。对于定制化(如定制代码接口或定制报告工具)和/或需要配置(如,在软件中配置安全权限,或在网络架构中配置硬件)的,系统应在一个适当的书面的质量管理体系下进行开发。

Custom-developed systems
定制开发系统

9.3. For  custom-developed  systems  and  configurable  systems,  the  system  should  be developed under an appropriate documented quality system. For these systems or modules the quality management system controls should include development of code in accordance with documented programing standards, review of code for adherence to programing standards and designspecificationsanddevelopmenttestingthatmayincludeunittestingand module/integration testing.
对于定制开发系统和可配置系统,系统的开发应在一个适当的书面的质量体系下进行。对于这些系统或模块,质量管理体系控制应包括符合书面编程标准的代码开发、用以确认符合编程标准和设计标准的代码审核、和开发测试,包括单元测试和模块/集成测试。

9.4. System  prototyping  and  rapid,  agile  development  methodologies  may  be  employed during the system build and development testing phase. There should be an adequate level of documentation of these activities.
可在系统构建和开发测试阶段采用系统原型法和快速的、灵活的开发模式。对于这些活动,应具备充分的记录。

Preparation for the system qualification phases
系统确认阶段准备

9.5. The system development and build phase should be followed by the system qualification phase.  This  typically  consists  of  installation,  operational  and  performance  testing.  Actual qualification required may vary depending on the scope of the validation project as defined in the validation plan and based upon a documented and justified risk assessment.
系统确认阶段应在系统开发和构建阶段之后。确认阶段通常由安装、运行和性能测试组成。实际所需的确认可能取决于验证计划中制定的验证项目范围,并基于书面合理的风险评估。

9.6. Prior  to  the  initiation  of  the  system  qualification  phase,  the  software  program  and requirements and specifications documents should be finalized and subsequently managed under formal change control.
在系统确认阶段开始前,软件程序和需求及规范文件应定最终确定,并后续按照正式变更控制程序管理。

9.7.  Persons who will be conducting the system qualification should be trained to adhere to the following requirements for system qualification:
实施系统确认的人员应接受培训,使其遵守以下系统确认的要求:

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test documentation should be generated to provide evidence of testing;
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应形成测试记录以提供测试证据
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test documentation should comply with good documentation practices;
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测试记录应符合良好文件记录实践
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any discrepancies between actual test results and expected results should be documented and  adequately resolved based upon risk prior to proceeding to subsequent test phases.
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应记录所有实际测试结果和预期结果之间的偏离,并根据风险在继续下一个测试阶段前被充分地解决。
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10.  INSTALLATION QUALIFICATION
安装确认

10.1. Installation qualification (IQ), also referred to as installation verification testing should provide documented evidence that the computerized system, including software and associated hardware, is installed and configured in the intended system test and production environments according to written specifications.
安装确认(IQ),也称为安装确认测试,应提供计算机化系统,包括软件和相关硬件,已按照书面程序安装和配置在预期的系统测试和生产环境。

10.2. The IQ will verify, for example, that the computer hardware on which the software application is installed has the proper firmware and operating system, that all components are present and in the proper condition and that each component is installed per the manufacturer or developer instructions.
IQ 将确认,如安装软件程序的计算机硬件具备适当的固件和操作系统,所有的组件都存在并且处于合适的环境下,即每个组件都按照生产商或开发商的指导进行安装。

10.3. IQ should include verification that configurable elements of the system are appropriately set as specified. Where appropriate, this could also be done during operational qualification(OQ).
IQ 应包括确认系统配置要素按要求进行了设置。在适当情况下,这部分也可以在运行确认(OQ)中完成。

11.  OPERATIONAL QUALIFICATION
运行确认

11.1. The  OQ,  or  operational/functional  verification  testing,  should  provide  documented evidence that software and hardware function as intended over anticipated operating ranges.
OQ,或者运行/功能确认测试,应提供软件和硬件功能在预期运行范围内符合预期的书面证明。

11.2. Functional testing should include, based upon risk:
根据风险,功能测试应包括:

·
an appropriate degree of challenge testing (such as boundary, range, limit, nonsense entry testing) to verify the system appropriately handles erroneous entries or erroneous use;
·
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。
·
·
verification that alarms are raised based upon alarm conditions;
·
确认在警报条件下能触发报警
·
·
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:

·
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
·
·
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
·
·
mechanisms for signing electronic data,
·
签署电子数据的机制
·
·
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:

·
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
·
·
backup/restore,
·
备份/恢复
·
·
archival/retrieval,
·
归档/检索
·
·
disaster recovery and business continuity,
·
灾难恢复和业务连续性
·
·
change management,
·
变更管理
·
·
incident and problem management,
·
事件和问题管理
·
·
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:

·
performance monitoring;
·
性能监测
·
·
change management and configuration management;
·
变更管理和配置管理
·
·
problem/incident management;
·
问题/事件管理
·
·
program and data security;
·
程序和数据安全
·
·
program and data backup/restore and archival/retrieval;
·
程序和数据备份/恢复和归档/检索
·
·
system administration and maintenance;
·
系统管理和维护
·
·
data flow and data life cycle;
·
数据流和数据生命周期
·
·
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
·
·
personnel training;
·
人员培训
·
·
disaster recovery and business continuity;
·
灾难恢复和业务连续性
·
·
availability of spare parts and technical support;
·
备件供应情况和技术支持
·
·
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:
·
review of changes;
·
变更回顾
·
·
review of deviations;
·
偏差回顾
·
·
review of incidents/ events;
·
事件回顾
·
·
systems documentation;
·
系统文件
·
·
procedures;
·
规程
·
·
training;
·
培训
·
·
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。

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