ISPE data integrity by design 瞎翻译 瞎研读

wudizzx

火页仔 发表于 2021-9-26 10:25

简单说一下个人对于“数据完整性”和“数据质量”的区别。前者是一个数据的基本要求，一个合格的数据必须要具备数据完整性的ALCOA+的要求；而质量是一种属性，他不是一个必须要达成的内容，但不同场合对于不同的数据我们会有不同的数据质量的要求。
我拿三文鱼刺身举个例子，无毒、干净、卫生、没有过期，是我们最基本的要求，可以等价于数据完整性，而质量，不同产地、不同品种、不同部位、包括不同的应用场合（国宴、自己随便吃等等）都会给三文鱼带来不同的质量属性。
指南也说了，后面的附录会有例子来解释的。

火页仔

原文	翻译	感想
A Unifying Strategy for Data and System Governance	数据和系统管理的统一策略	之前在建体系的时候，DI是DI 系统是系统 现在既然全盘电子化，那就没必要分开了 我也觉得这样才是更加符合大家的第一反应的做法
Governance can take place at many levels within an organization, for example, global, regional, group, national, site wide, departmental, process, project.	治理可以在一个组织内的许多层面上进行，例如，全球、区域、集团、国家、整个工厂、部门、过程、项目。	N/A
From a governance point of view, “data integrity by design” can be restated as “data integrity by intent.”	从管理的角度来看，“数据完整性基于设计”可以重述为“数据完整性基于意图”。	高深了
There needs to be a clear mandate at every level of governance that achieving data integrity through intentional design is a business-critical requirement, one that will be supported, endorsed, and resourced.	在各级治理中都需要有一个明确的任务，即通过有意的设计实现数据完整性是一个业务关键的要求，将得到支持、认可和资源。	N/A
This should be a commitment not just for the quality unit, but for all functions involved in the design, implementation, validation, and operation of the business process.	这不仅是对质量部门的承诺，也是对业务流程设计、实施、验证和操作中涉及的所有职能的承诺。	想表达个啥
Governance to achieve data integrity and governance for the validation of computerized systems within a regulated organization have been discussed in the ISPE GAMP® Guide: Records and Data Integrity [8] and ISPE GAMP® 5 [9] respectively.	ISPE GAMP指南：记录和数据完整性和ISPE GAMP®5中分别讨论了实现数据完整性的管理以及在受监管组织内计算机化系统验证的管理。	这个我们已经了然于心了
Validation of computerized systems for intended use is necessary to achieve data integrity, while data integrity requirements must be considered as part of each validation effort in order to ensure that ALCOA+ imperatives are delivered	基于预期用途的计算机化系统的验证对于实现数据完整性是必要的，而数据完整性要求必须被视为每项验证工作的一部分，以确保提供ALCOA + 要求	N/A
When determining and establishing governance approaches to achieve data integrity by design, there is an integral relationship between data integrity and computerized system validation that must be recognized in the corporate Quality Management System (QMS).	在确定和建立通过设计实现数据完整性的管理方法时，必须在公司质量管理体系(QMS)中识别出数据完整性和计算机化系统验证之间存在的不可或缺的关系。	好的
The data needs will in turn create the risk scenarios that ultimately drive the configuration and validation activities for the computerized system.	数据需求将反过来创建最终驱动计算机化系统配置和验证活动的风险场景。	本来不就是这样吗？
Data, and the regulated use of the data, are the drivers for many project activities within the system lifecycle.	数据和数据的规范使用是系统生命周期内许多项目活动的驱动因素。	N/A
The system lifecycle ensures that ongoing controls are established and verified to make certain the data is appropriately and effectively managed throughout the data lifecycle.	系统生命周期可以确保建立并验证持续的控制措施，以确保在整个数据生命周期内适当有效地管理数据。	N/A
Table 2.1 shows a list of practices that are shared by good governance frameworks for both data integrity and computerized system validation.	表2.1显示了数据完整性和计算机化系统验证的良好治理框架所共有的做法清单。	让我们看看有些啥

•高级管理层的帮助和参与

•明确的角色和职责

•提供足够的资源

•培训支持

•关注患者安全、产品质量，和数据完整性

•基于风险的方法

•利用供应商参与

•QMS的一部分

•持续改进

•可增减的步骤

•变更控制和配置管理

•访问控制

•信息安全和网络安全

•定期审查和评价

•灾难恢复/业务连续性计划

•备份和恢复

•存档和检索

•积极管理数据保留和销毁

•信息技术支持

我不知道你们有没有发现什么新东西，反正我是没有

火页仔

原文	翻译	感想
A company-wide data integrity by design strategy should be established as early as possible in the development of any significant data integrity initiative.	在制定任何重要的数据完整性计划时，应尽早建立全公司的基于设计的数据完整性策略。	咱们就当咱们都是要新建流程的人吧
It may also be appropriate to determine a data integrity by design strategy at a lower level, such as for a specific business process or project.	也可以在较低级别的设计策略来确定数据完整性，例如对于特定的业务流程或项目。	你上面也说过了，能不能不要这么啰嗦 能不能！
Effective data integrity by design should follow a risk-based approach that encompasses the full business process lifecycle.	通过设计实现的有效数据完整性应遵循包含整个业务流程生命周期的基于风险的方法。	像这种啰嗦的 重复的屁话 我之后就直接N/A了 因为我的吐槽语库已经空了
This lifecycle addresses data (creation, processing, reporting and use, retention and destruction) and, by implication, the lifecycle phases of all associated computerized systems (concept, project, operation, retirement).	该生命周期涉及数据（创建、处理、报告和使用、保留和销毁），并暗示所有相关计算机系统的生命周期阶段（概念、项目、操作、报废）。	N/A
For a regulated organization, the scope of governance activities to achieve data integrity by design should cover GxP processes, data lifecycles, and computerized systems.	对于受监管的组织，通过设计实现数据完整性的管理活动范围应涵盖GxP流程、数据生命周期和计算机化系统。	N/A
The same governance elements are required whether the component(s) of the computerized system are on-premise or leverage a service-based architecture (e.g., Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Software as a Service (SaaS)).	无论计算机化系统的组件是本地的还是利用基于服务的架构（例如，作为服务的基础设施(IaaS)、作为服务的平台(PaaS)、作为服务的软件(SaaS)），都需要相同的治理要素。	N/A
This governance scope is shown schematically in Figure 2.3.	此治理范围的示意图如图2.3所示。	N/A
This diagram is an abstract representation of the need for, and relationship between, the data lifecycle and system lifecycle for the computerized systems involved in the creation, processing, review, reporting and use, retention and destruction of the data within a business process.	该图是在业务流程中参与创建、处理、审查、报告和使用、保留和销毁数据的计算机化系统的数据生命周期和系统生命周期的需求和关系的抽象表示。	N/A
The data lifecycle should be considered both within the context of the system lifecycle and separate to it.	系统生命周期的背景下或系统生命周期背景外，都应考虑数据生命周期。	N/A
The lifecycles run on independent timelines in that the data may outlive the system and need alternative arrangements for retention after system retirement, or conversely, the system may continue in operation long after the retention period has expired for a specific data set.	生命周期在独立的时间线上运行，因为数据可能超过系统寿命，并且在系统报废后需要其他保留安排，或者相反，在特定数据集的保留期限到期后，系统可能会继续运行很长时间。	这句话解释了上面一句 所以就是既要DI和CSV既要协同考虑 又要考虑到两者有区分开的需要
Within the operational phase of the system lifecycle, change control and configuration management are essential to maintain the validated state of the system.	在系统生命周期的运行阶段，变更控制和配置管理对于维持系统的确认状态至关重要。	N/A
The roles and responsibilities depicted at the top and bottom of the diagram in Figure 2.3 need to be defined and assigned to the appropriate individuals, and may only be meaningful through specific phases of the two lifecycles.	图2.3中图的顶部和底部描述的角色和职责需要定义并分配给适当的个人，并且只能在两个生命周期的特定阶段中有意义。	N/A
Of these roles, data ownership is a critical concept to ensure data integrity throughout the data lifecycle.	在这些角色中，数据所有权是确保整个数据生命周期内数据完整性的关键概念。	N/A
Regardless of where the data resides (on- or off-premise) or where it is generated (Contract Manufacturing Organization (CMO), Contract Research Organization (CRO), etc.), data ownership remains with the regulated company.	无论数据在何处保存（现场或非现场）或在何处生成（合同生产组织(CMO)、合同研究组织(CRO)等），数据所有权仍归受监管公司所有。	现在没有人会觉得可以把这个责任推给第三方把？
Figure 2.3 shows that processes to manage records and data throughout the data lifecycle must be considered in the initial data integrity by design phase.	图2.3显示，在通过设计保证数据完整性的初始阶段，就应该考虑在整个数据生命周期中管理记录和数据的流程是怎样的	反正就是不考虑现存企业的情况呗 让我们看看那一个专门讲现存企业的章节会说些什么吧
Data lifecycles can transcend multiple systems, with data flow between the systems.	数据生命周期可以跨越多个系统，系统之间有数据流。	N/A
Overall, a data flow diagram of the complete business process is an essential requirement for data integrity by design.	总体而言，完整业务流程的数据流图是数据完整性基于设计的基本要求。	APIC的指南里就是这么做的呀
To consistently achieve an effective design that delivers compliance throughout the data lifecycle, the retention requirements must be understood when defining the business process specification.	为了始终实现在整个数据生命周期内提供合规性的有效设计，在定义业务流程质量标准时必须理解数据保存的要求。	N/A
In many circumstances it may be ineffective to consider only the lifecycle of the data within a single system because data may be transferred across multiple systems (computerized or paper-based) as part of the data flows required to construct the regulated record.	在许多情况下，仅考虑单个系统内数据的生命周期可能是无效的，因为数据可能作为构建受监管记录所需数据流的一部分跨多个系统（计算机化或纸质）传输。	讲过了！讲过了！
Where copies of the data exist in more than one system (e.g., source and target systems), it is important to understand:	如果数据副本存在于多个系统中（例如，源系统和目标系统），重要的是要了解：	N/A
• The scope of the data use • Which record will be used to make any decision under the predicate rules • How it will be assured that the data is current and complete	•数据使用范围 •哪些记录将用于根据既定规则做出任何决定 •如何确保数据是最新和完整的	N/A
It is also possible that a single system supports multiple business processes, for example, a document management system.	也有可能单个系统支持多个业务流程，例如文档管理系统。	N/A
Consequently, the retention and other data integrity aspects from several processes may need to be considered in the system design and implementation.	因此，在系统设计和实现中可能需要考虑几个流程的数据保存和其他数据完整性方面。	N/A
A holistic approach to data integrity by design is therefore required over the full data lifecycle(s) for all impacted regulated data.	因此，对于所有受影响的监管数据，在整个数据生命周期内需要通过设计对数据完整性采取整体管理方法。	N/A

火页仔

原文	翻译	感想
Data Ownership	数据所有权	N/A
Considerations on Ownership	所有权的考量	N/A
Consider a business process that is not computerized.	假设有一个非计算机化的业务流程。	N/A
The (business) process owner is accountable for all aspects of the process.	（业务）流程负责人应对流程的所有方面负责。	N/A
Once the business process is supported by a computerized system, accountabilities are divided into two separate aspects: process ownership and system ownership (responsible for the computerized system, as discussed below).	一旦业务流程获得了计算机化系统的支持，责任就分为了两个独立的方面：流程所有权和系统所有权（负责计算机化系统，如下文所述）。	这也是很多公司内职责划分的撕逼起源之处
Those activities associated with the performance of the business process remain with the process owner;	与业务流程履行相关的活动应由流程负责人负责；	N/A
the separate role of system owner has accountability for those activities related to the technical support and maintenance of the computerized system.	系统所有者的单独角色负责与计算机化系统的技术支持和维护相关的活动。	IT做好支持活动就好 实际情况中，有的IT不甘寂寞 有的业务部门畏首畏尾
The process owner has accountability for the quality and integrity of the entire business process including the process data throughout its data lifecycle, but may delegate data responsibility to data owner(s) at specified phases of the data lifecycle.	流程负责人应对整个业务流程（包括其数据生命周期内的流程数据）的质量和完整性负责，但可在数据生命周期的指定阶段将数据责任委派给数据负责人。	N/A
As a further level of complexity, the business process itself may be divided into subprocesses.	随着复杂程度进一步升级，业务流程本身可以分为子流程。	N/A
The process owner may delegate some or all their responsibilities to sub-process owners, which may also include delegation of system and data ownership.	流程负责人可将其部分或全部职责委托给子流程负责人，这也可能包括系统和数据所有权的委托。	这也需要花这么多篇幅阐述？ 哪个组织机构不是这样？
A hierarchy of process, system, and data owners is thus established, as depicted in Figure 2.4.	因此，建立了过程、系统和数据所有者的层次结构，如图2.4所示。	N/A
The subprocesses can each contain one or more computerized systems.	子流程可以包含一个或多个计算机化系统。	N/A
Data ownership and system ownership creates a matrix of responsibilities as delegated data ownership may be aligned with, for example, specific clinical trials, sites, or products, while the data may be processed in multiple systems.	数据所有权和系统所有权形成了一个职责矩阵，因为委托下放的数据所有权可能与特定临床试验、研究中心或产品一致，而数据可能在多个系统中处理。	所以这句话想说明个啥
Data should never be without a designated owner at any point in the data lifecycle;	在数据生命周期的任何时间点，数据均不得无指定所有者；	N/A
effective handover of data ownership responsibilities between individuals transitioning to/from an organization role (with designated data ownership responsibility) is critical to successful maintenance of data integrity and data quality.	有效交接数据所有权责任对于成功维护数据完整性和数据质量至关重要。	最近学了一句新的吐槽：听君一席话，如听一席话
When considering the computerization of a complex process, the overall process owner should understand the intended scope of the computerization and ensure the involvement of all subsidiary process, system, and data owners.	在考虑复杂过程的计算机化时，整个过程所有者应了解计算机化的预期范围，并确保所有辅助过程、系统和数据所有者的参与。	N/A

火页仔

原文	翻译	感想
Principles of Data Ownership	数据所有权的各种原则	N/A
It is important for an organization to establish and maintain a culture that supports data integrity and to have clear policies for data governance.	一个组织必须建立和维护支持数据完整性的文化，并有明确的数据管理政策。	还要你说？
Data governance should address data ownership throughout the data lifecycle to make certain data integrity risks are addressed throughout the data lifecycle.	数据管理应涉及整个数据生命周期内的数据所有权，以确保在整个数据生命周期内解决某些数据完整性风险。	用得着你告诉我？
Electronic systems have become integral to most business processes within the life science industry, and with this evolution comes the need to understand what data is captured and who owns it.	电子系统已经成为生命科学行业内大多数业务流程的组成部分，随着这种演变，需要了解捕获了哪些数据以及谁拥有这些数据。	N/A
The concept of data ownership is not new and applies equally to paper data and electronic data. The ease of movement of electronic data makes data ownership more complex.	数据所有权的概念并不新鲜，同样适用于纸质数据和电子数据。电子数据移动的便利性使得数据所有权更加复杂。	N/A
Data ownership is often defined at a company level, but is then refined to the system level (documented in the roles and responsibilities section of the system Standard Operating Procedures (SOPs)) or even to a specific project (documented in the quality and project plan) or clinical trial (documented in the trial master file or other trial configuration documentation).	数据所有权通常在公司层面定义，但随后细化至系统水平（记录在系统标准操作规程(SOP)的角色和职责章节），甚至细化至特定项目（记录在质量和项目计划中）或临床试验（记录在试验主文件或其他试验配置文件中）。	N/A
The data owner must understand the business value of the data and often has a position of responsibility within the business unit generating the data.	数据所有者必须了解数据的业务价值，并且通常在生成数据的业务部门内有责任。	你在搞笑吗？不然呢？管QC的会不知道QC的数据是干嘛的？管生产的会不知道生产的数据是干嘛的？ 或者他们在自己部门里都说不上话？ 你操的哪门子空心呢？
Individual organizations should allocate roles and responsibilities based on organizational structure and the specific system involved.	各组织应根据组织结构和涉及的具体系统分配角色和职责。	N/A
The organization needs to establish policies and procedures to support the role of data owner and ensure it is appropriately resourced for each business process or system.	该组织需要制定政策和程序来支持数据所有者的角色，并确保每个业务流程或系统都有适当的资源。	我TM需要的是你告诉我怎么做 OK？不是来听你讲这么些大道理
Data ownership can be a subset responsibility of the process owner (see ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts [16]). As defined within ISPE GAMP® 5 [9], the process owner is:	数据所有权可以是流程所有者的一个子集责任（参见ISPE GAMP RDI良好实践指南：数据完整性-关键概念）。根据ISPE GAMP 5的规定，流程负责人为：	真是看着看着火气又上来了
“the person ultimately responsible for the business process or processes being managed.	“对所管理的业务流程或流程负有最终责任的人士。
This person is usually the head of the functional unit or department using that system, although the role should be based on specific knowledge of the process rather than position in the organization.	该人员通常是使用该系统的职能单位或部门的负责人，尽管该角色应基于对该过程的具体知识，而不是在组织中的职位。	管理负责人不一定是技术负责人。
The process owner is responsible for ensuring that the computerized system and its operation is in compliance and fit for intended use in accordance with applicable Standard Operating Procedures (SOPs) throughout its useful life….Ownership of the data held on a system should be defined and typically belongs to the process owner.”	流程负责人负责确保计算机化系统及其操作在其使用寿命期间符合适用的标准操作规程(SOP)，并适合于预期用途……应定义系统上数据的所有权，通常属于流程负责人。”	N/A

补充内容 (2021-10-4 15:20):
需要补充一下：某个业务的数据所有者是业务流程所有者委托的一个职位，这个职位的人不一定要懂业务，但是应该要懂数据

火页仔

原文	翻译	感想
Responsibility of the Data Owner	数据所有者的职责	N/A
The data owner is responsible for the integrity of the data, and for defining the quality requirements for the data and how the data is to be used.	数据所有者负责数据的完整性，并定义数据的质量要求和如何使用数据。	N/A
Because electronic data is easily shared, there is a need to make sure that the data owner maintains awareness of the use of the data.	由于电子数据易于共享，因此需要确保数据所有者时刻了解数据是如何被使用的。	N/A
In the case of clinical trial data and medical records, the data owner must protect the interests of the patient and their confidential data.	如果是临床试验数据和病历，数据所有者必须保护患者的利益和他们的机密数据。	N/A
Non-GxP regulations such as GDPR [17] and HIPAA [18] may also impact patient data.	GDPR和HIPAA等非GxP法规也可能影响患者数据。	N/A
The data owner must be knowledgeable about how the data is used throughout the data lifecycle (data that may span the organization), and how and where it is retained in a secure archive for the required period.	数据所有者必须了解在整个数据生命周期中数据是如何使用的（可能跨越组织的数据），以及在所需时间内数据如何安全保存，包括其保存的位置。	N/A
Data ownership is typically associated with a particular job title or function in the organization, and each new person to that job inherits the data ownership.	数据所有权通常与组织中的特定职称或功能相关联，该工作的每个新人员都继承数据所有权。	跟职位挂钩
Where an internal reorganization impacts job roles and responsibilities, special attention should be paid to ensure that data ownership is not lost or overlooked.	如果内部重组影响工作角色和职责，应特别注意确保数据所有权不会丢失或被忽视。	嗯 谢谢你提醒哈
Where data crosses organizational boundaries within the process, data ownership may be transferred to a new data owner, although the original data owner may always remain accountable for the original data generated within their scope.	如果数据在流程内跨越组织界限，则可以将数据所有权转移给新的数据所有者，尽管原始数据所有者可能始终对其范围内生成的原始数据负责。	谁的职权范围内生成的数据就由谁负责
For example, analytical data owned by the Quality Control (QC) laboratory may be incorporated into a manufacturing batch record, which has its own data owner.	例如，质量控制(QC)实验室拥有的分析数据可以合并到生产批记录中，而生产批记录有自己的数据所有者。	虽然合并了 但是QC的分析数据的数据所有者还是QC的人 稍微讲道理的人都不会否认这一点吧
In the event of an investigation or audit, any queries about the analytical data within the batch record requires assistance from the QC laboratory data owner.	如果进行调查或稽查，对批记录中分析数据的任何质疑均需要QC实验室数据所有者的协助。	N/A
Uncertainty in data ownership can be introduced during mergers and acquisitions and should be resolved as part of the integration process, see Section 3.7.	在合并和收购过程中可能会引入数据所有权的不确定性，应作为整合过程的一部分进行解决，见第3.7节。	N/A
It is important to separate the data owner from the system owner, who is responsible for system maintenance roles (for example, IT groups responsible for the operating system, application, and database), to prevent a conflict of interest.	重要的是将数据所有者与系统所有者分开，后者负责系统维护角色（例如，负责操作系统、应用程序和数据库的It小组），以防止利益冲突。	说白了，跟系统管理员不能是业务相关人员是一个道理
With current working practices, interest in the data often spans different departments (e.g., IT security is concerned about safeguarding the data, and the legal department may be concerned with data privacy.)	根据目前的工作实践，对数据的兴趣通常跨越不同的部门（例如，IT安全担心保护数据，法律部门可能担心数据隐私。）	N/A
Data owners have a direct interest in the data and therefore should not have system administration and/or privileged accounts.	数据所有者对数据有直接兴趣，因此不应拥有系统管理和/或特权账户。	说得有道理，虽说IT，legal不是业务直接相关方，但是说他们完全没有利益兴趣也说不通。
Many organizations create a data steward role for the technical people with day-to-day responsibility for the data.	许多组织为日常负责数据的技术人员创建数据管理角色。	N/A
Data stewardship activities may be embedded in the responsibilities of other roles, rather than being a new and specific individual role.	数据管理活动可以嵌入到其他角色的职责中，而不是作为一个新的和特定的个人角色。	N/A
The Data Steward role is defined in the ISPE GAMP® Guide: Records and Data Integrity [8] as:	ISPE GAMP指南：记录和数据完整性中将数据管理员角色定义为：	N/A
“A person with specific tactical coordination and implementation responsibilities for data integrity, responsible for carrying out data usage, management, and security policies as determined by wider data governance initiatives, such as acting as a liaison between the IT department and the business.	“对数据完整性负有特定战术协调和实施责任的人员，负责执行数据使用、管理和安全政策，例如作为IT部门和业务之间的联络人。	看到这里我才意识到 确实有很多公司在各个部门内设置了这种岗位。
They are typically members of the operational unit or department creating, maintaining, or using the data, for example personnel on the shop floor or in the laboratories who actually generate, manage, and handle the data.”	他们通常是创建、维护或使用数据的运营单位或部门的成员，例如车间或实验室中实际生成、管理和处理数据的人员。”	生成数据？然后还要管理和处理数据？英文中用的是and？ 这能没有利益冲突？

火页仔

原文	翻译	感想
Data Owner Involvement in Infrastructure Changes	数据所有者参与基础设施变更	N/A
In IT Service Management (ITSM), a platform change (e.g., database migration or cloud hosting provider migration) may often be considered an infrastructure change, which involves the system owner but not necessarily the business process owner.	在IT服务管理(ITSM)中，平台变更（例如：数据库迁移或云托管提供商迁移）通常被视为基础设施变更，其中涉及系统所有者，但不一定是业务流程所有者。	N/A
At a minimum, the data owner (as delegated by the business process owner) should be consulted before any change occurs and be kept informed through its implementation.	在任何变更发生之前，至少应咨询数据所有者（由业务流程所有者委托），并在变更实施过程中告知数据所有者。	没毛病
At all times, the data owner should know where the data resides, and the process followed to verify any data migrations, considering the mechanism used, reliance on network bandwidth during migration, error reporting tools used, any data transformation etc., such as non-Unicode™ to Unicode™ conversion, or database changes from SQL to Oracle®.	在任何时候，数据所有者都应该知道数据保存的位置，并遵循流程来验证任何数据迁移，考虑使用的机制、迁移过程中对网络带宽的依赖、使用的错误报告工具、任何数据转换等，例如非Unicode™到Unicode™的转换，或数据库从SQL到Oracle®的变化。	业务流程所有者委托的数据所有者还是要懂数据相关的背景
The level of verification should be commensurate with the risks of the infrastructure change and any migration involved.	验证水平应与基础设施变更和任何相关迁移的风险相称。	也是老生常谈了

原文	翻译	感想
Data Ownership Across Multiple Organizations	多个组织的数据所有权	N/A
Data ownership may be simple when a single organization owns and uses the data throughout the data lifecycle, but when the creation, processing, and/or reporting of data is contracted to a second organization, the concept of data ownership becomes more complex.	当单个组织在整个数据生命周期中拥有和使用数据时，数据所有权可能很简单，但当数据的创建、处理和/或报告被承包给第二个组织时，数据所有权的概念变得更加复杂。	这个情况上面有内容讲到了吧 哪里generate就哪里own
The contract giver or sponsor company legally owns the data (even if they only use data in summary form), while the contract acceptor may be the entity responsible for the creation, processing, and reporting of the data.	合同委托方或申办方公司依法拥有数据（即使其仅使用总结形式的数据），而合同接受方可能是负责创建、处理和报告数据的实体。	这个也没什么争议吧
The contract acceptor should have a data steward to address the day-to-day data responsibilities within the contract organization, and report all concerns and risks to the data owner within the contract giver company who is ultimately responsible for data ownership.	合同接受方应具有数据管理员，以解决合同组织内的日常数据责任，并将所有问题和风险报告给合同提供方公司内的数据所有者，合同提供方公司最终负责数据所有权。	现实情况是，绝大部分第三方都搞不清楚这些东西，这些约束条款都需要作为被监管机构的甲方在各种合同，质量协议里面去讲清楚。 所以我一看到什么依靠第三方去解决问题这种东西就觉得特别扯淡
The contract acceptor may be responsible for the data throughout the data lifecycle.	受托方可能对整个数据生命周期内的数据负责。	N/A
All of these responsibilities and expectations must be clearly defined within the quality contract and/or technical agreement and verified through the vendor qualification process.	所有这些责任和期望必须在质量合同和/或技术协议中明确定义，并通过供应商资格认证过程进行验证。	你如果不懂的话 你猜你的供应商会不会，能不能让你充分依靠呢？
In an environment involving multiple organizations, a robust communication plan is necessary to ensure potential data integrity issues are reported to the “legal” data owner.	在涉及多个组织的环境中，有必要制定稳健的沟通计划，以确保向“合法”数据所有者报告潜在的数据完整性问题。	没错，这种沟通机制的搭建也是你甲方的责任，因为最终还是你抗下所有。
In this context, potential data integrity issues are not limited to instances of suspected data manipulation but also include cyberattacks or security breaches, and the report should address the impact of these events.	在这种情况下，潜在的数据完整性问题不仅限于疑似数据操纵的情况，还包括网络攻击或安全漏洞，报告应说明这些事件的影响。	N/A

火页仔

原文	翻译	感想
Retention Strategy	保存策略	看到这个标题让我对这个章节的内容有了一丝丝期待 该讲点接地气的东西了吧 但是策略两个字又让我心头有了一丝不安
A strategy should be developed to ensure the long-term retention of regulated or operational data output by a business process.	应当制定策略，以确保长期保存业务流程输出的监管或操作数据。	嗯 先定个调，怎么着得有个策略管数据的保存
The retention strategy should focus on the management of the data throughout its lifecycle, not just on the initial creation of data within the process.	保存策略应侧重于整个生命周期内的数据管理，而不仅仅是过程中数据的初始创建。	先忍你几句废话
Use of electronic records as the original/official records supporting business processes continues to increase.	电子记录作为支持业务流程的原始/官方记录的使用继续增加。	N/A
Therefore, it is imperative to apply critical thinking to develop the retention strategy in the planning phase for a new process or system.	因此，在新的过程或系统的规划阶段，应用批判性思维制定保存策略势在必行。	动辄批判思维
This will help ensure data is maintained in its dynamic format throughout the data lifecycle as long as reasonably possible.	这将有助于确保数据在整个数据生命周期内以其动态格式尽可能长时间地保存。	动态格式是重点
The risk is that as technology advances, old file types become obsolete, driving companies to:	风险在于，随着技术的进步，旧文件类型会过时，促使公司：	N/A
• Maintain obsolete technology to continue to read and access the files, which can increase data integrity risks	•保持过时的技术继续阅读和访问文件，这会增加数据完整性风险	N/A
• Migrate the data so that new technology can continue to read the record	•迁移数据，以便新技术能够继续读取记录	迁移数据也是有风险的
There are risks associated with any strategy, and assessing those risks and planning a broad methodology for record and data retention at the beginning of a system’s lifecycle allows the plan to be adjusted as technology changes or as systems go through their lifecycle.	任何策略都有风险，在系统生命周期开始时评估这些风险并计划广泛的记录和数据保存方法，允许随着技术变化或系统通过其生命周期对计划进行调整。	你的意思是在系统生命周期初期就要考虑到后面的所有技术变化？ 那这个要求不低哦，能做到的供应商出来举个手 合同里写一下技术更新以后的服务策略
As such, it is imperative for a company to have a strategy in place that will lead their employees through the process; without this, the company increases its risk as the system moves toward its end of life.	因此，公司必须有一个战略来领导员工完成这一过程；如果没有这个战略，随着系统走向临终，公司就会增加其风险。	如果说思考的点在于，提前想好目前这个系统的迭代方案，可能还相对简单一点
The longer a system goes without a retention strategy, the greater the likelihood the company will lose the ability to migrate or maintain records to the end of their retention period.	系统在没有保存策略的情况下运行的时间越长，公司失去迁移或维护记录至其保留期结束的能力的可能性就越大。	好好好，告诉我策略是啥
Typically, as data ages, the need for it to be processible decreases until at some point, a risk-based decision to change to a static format may be appropriate. This is discussed in Section 7.2.	通常，随着数据的老化，对其可处理性的需求降低，直到某个时间点，基于风险的变更为静态格式的决策可能是适当的。这在第7.2节中讨论。	嗯 这个点不错
In order for data integrity to be ensured within the system and data lifecycles, a retention strategy should be crafted during the design phase and ensure that data remains secure and protected from deliberate or accidental changes, manipulations, or deletions throughout the retention period.	为了确保系统和数据生命周期内的数据完整性，应在设计阶段制定保存策略，并确保在整个保存期间数据保持安全，防止故意或意外变更、操作或删除。	废话又来了
The strategy for archiving GxP data also needs to be planned, whether it is archived electronically or using a paper-based system.	还需要计划GxP数据的归档策略，无论是电子归档还是使用纸质系统归档。	N/A
An electronic archiving system, both hardware and software, must be designated as a computerized system and validated to ensure the integrity of the data, and make certain that it is accessible and readable. See Appendices O2 and O3 for more details on archiving requirements.	电子归档系统（包括硬件和软件）必须被指定为计算机化系统，并经过验证以确保数据的完整性，并确保其可访问和可读。有关存档要求的更多详细信息，请参见附录O2和O3。	我想知道能是电子归档的企业能有多少。。哈哈
The data governance for the records in any new computerized system and the archive solution should be aligned early.	任何新的计算机化系统中记录的数据管理和归档解决方案应尽早保持一致。	结合下面一句话，我的理解是新上系统必须要和归档系统相适配 免得新系统的数据归档以后不可读？
Where problems with long-term access to data are envisaged, or when computerized systems must be retired, mitigation strategies for ensuring continued readability of the data should be established.	如果可以预见到长期获取数据存在问题，或者必须停用计算机化系统，则应制定缓解策略，以确保数据的持续可读性。	是伐？
These may include virtualization of the original computerized systems, which is discussed in Appendix O5.	这可能包括附录O5中讨论的原始计算机化系统的虚拟化。	好高级的亚子
As regulated companies increasingly utilize cloud-based services, a SaaS provider may need to offer appropriate strategies to ensure adequate controls are in place for data retention.	随着受监管公司越来越多地利用基于云的服务，SaaS供应商可能需要提供适当的策略，以确保对数据保存进行充分控制。	嗯 也是个趋势
See ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) [19] for additional considerations around cloud-based services and data retention.	有关基于云的服务和数据保存的其他注意事项，请参阅ISPE GAMP良好实践指南：IT基础设施控制和合规性（第二版）。	N/A
The high-level elements of the strategy should be defined in a corporate data governance document as discussed in ISPE GAMP® Guide: Records and Data Integrity Section 3.3.6 Policies and Standards [8], listing the necessary elements, plus ones to consider, for the record retention of a system or project.	如ISPE GAMP指南：记录和数据完整性第3.3.6节政策和标准所述，应在公司数据管理文件中定义战略的高级别要素，列出系统或项目记录保存所需的必要要素以及需要考虑的要素。	N/A
Refer to Appendix O1 – Retention, Archiving, and Migration [8] of the same Guide for information on how to document the retention strategy for a particular system.	有关如何记录特定系统的保存策略的信息，请参阅同一指南的附录O1-保留、归档和迁移。	N/A
The key points to a retention strategy are knowledge and consideration of data classification and intended use, readability, availability, access, and data ownership.	保存策略的关键点是知识和数据分类和预期用途、可读性、可用性、访问和数据所有权的考虑。	N/A
A good place to start when developing a strategy is to document this information in the form of a risk assessment with the goal of documenting the business needs, associated risks, and current mitigation plans.	在制定策略时，一个很好的起点是以风险评估的形式记录这些信息，目标是记录业务需求、相关风险和当前缓解计划。	N/A
As new information becomes available over the system lifecycle, the assessment can be updated easily to reflect such changes.	随着新信息在系统生命周期内可用，可以很容易地更新评估，以反映此类变更。	N/A
See Figure 4.1 Data Integrity by Design Process Flow Diagram for an overview of the assessment during the system’s lifecycle.	系统生命周期内的评估概述见图4.1设计过程的数据完整性流程图。	N/A
This approach keeps the retention strategy up-to-date and representative of the current needs for the system against the ability and feasibility in technology.	这种方法使保存策略保持最新，并根据技术的能力和可行性代表系统当前的需求。	N/A
The following sections provide a more thorough breakdown of the details to consider.	以下章节提供了需要考虑的详细信息的更全面分类。	我刚要说果然只是个策略 马上又来吊胃口了 不愧是你

火页仔

原文	翻译	感想
Retention Periods	保存期	N/A
A regulated company generates many records with varied retention requirements during the course of its business processes, for example:	受监管公司在其业务流程期间生成具有不同保留要求的许多记录，例如：	N/A
• Regulated records subject to a mandated retention period • Regulated records retained beyond the minimum for business reasons (see Section 7.4.1) • Records of scientific innovation or invention (including drug development data) that may be needed in perpetuity for legal reasons • Financial records falling under the Sarbanes-Oxley Act 2002 (US) [20] (or similar legislation in other countries) • Records containing personally identifiable information (for example, human resources records and patient enrollment records for clinical trials) • Operational records needed solely for process improvements and business decisions (see Section 1.6.5).	•受规定保存期限约束的受监管的记录 •出于商业原因而导致保存超过最低限度的受监管记录（见第7.4.1节） •出于法律原因可能需要永久保存的科学创新或发明记录（包括药物开发数据） •符合2002年《萨班斯-奥克斯利法案》（US）的财务记录（或其他国家的类似立法） •包含个人身份信息的记录（例如，临床试验的人力资源记录和患者入组记录） •仅用于流程改进和商业决策的操作记录（参见第1.6.5节）。	不同的情况保存期要求不同
Each of these records are required to be available for a different duration depending on what, if any, legislation applies to that data classification (see Sections 1.6.5 and 4.4 for simple classification, and the more detailed example in ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts, Appendix 8 [16]).	根据适用于该数据分类的法规（如有），要求这些记录中的每一条在不同的时间要求下均可提供（简单分类见第1.6.5和4.4节，更详细的示例见ISPE GAMP RDI良好实践指南：数据完整性-关键概念，附录8）。	N/A
Even within the regulated records category, different retention periods are specified.	即使在受监管的记录的不同类别中，也规定了不同的保存期限。	其实这么长的篇幅就是想说明，不同类型的记录要求的保存期限会有所不同呗
Additionally, there may be legal and business reasons for extending retention periods, including possible future use of the record.	此外，可能存在延长保留期限的法律和商业原因，包括将来可能使用记录。	N/A
It is therefore important to identify what records fall under what legislation, and the applicable retention periods.	因此，重要的是要确定哪些记录属于哪些立法和适用的保留期限。	说白了就是首先要分好类 然后搞清楚各个类型的数据记录要保存多久
Where different records have drastically different retention periods (they can vary from 6 months to 30 years), it is important to segregate their storage.	如果不同的记录具有截然不同的保存期（它们可以从6个月到30年不等），则隔离它们的储存非常重要。	N/A
For example, a database containing a mixture of data (GLP, GCP, GMP, GDP, and business records) needs to be kept for the duration of the longest retention period of any of the records, giving rise to long-term storage of an excessively large amount of data, much of which is no longer required.	例如，需要在任何记录的最长保留期限内保存包含混合数据（GLP、GCP、GMP、GDP和业务记录）的数据库，从而长期存储过多的数据，其中大部分不再需要。	嗯嗯 是哦好有道理
Where an organization is creating data that is relevant to a number of other entities (e.g., training records within a Contract “x” Organization (CxO)), it is important that the organization has a clear approach for identifying and managing the data – both for operational use and when archiving/destroying data – for the individual entities. Implications concerning third-party data are discussed in Appendix M3.	如果一个组织正在创建与许多其他实体相关的数据（例如，合同“x”组织(CxO)内的培训记录），重要的是，该组织必须有一个明确的方法来识别和管理每一个CxO组织的数据——无论是用于业务用途还是在存档/销毁数据时。 关于第三方数据的影响见附录M3。	分门别类的重要性
The retention period, if not specified, should be sufficient to support any challenges to data integrity.	如果没有规定，保留期限应足以支持对数据完整性的任何挑战。	什么挑战，自个儿琢磨去吧
In the absence of a required retention period, the final disposition should be documented.	在没有规定保留期限的情况下，应记录最终处置情况。	额，难道有规定保留期限的情况下，最终处置的情况就不需要记录了吗？ 应该不是这个意思吧
Records should be protected to ensure they are accurate and readily retrievable throughout the retention period.	应对记录进行保护，以确保其在整个保存期间准确且易于检索。	基操
Readability is implied in retention period and discussed in Section 3.2. Readability of audit trails and other metadata is required under predicate rules to preserve the GxP content and meaning of the record, and should be retained and available for review and copying for at least as long as the original record.	可读性是指保留期限内的可读性，并在第3.2条中进行了讨论。根据既定的规则，要求审计跟踪跟踪和其他元数据的可读性，以保留记录的GxP内容和含义，并应至少与原始记录一样长的时间内保留和可供审查和复制。	还是基操
During system planning and selection, it is essential to include a user requirement for the ability to archive the complete data including audit trails and metadata.	在系统规划和选择过程中，用户需求中必须包括存档完整数据的能力，包括审计跟踪和元数据。	好家伙 回去想想你家系统有没有
Failure to meet this requirement could result in either an inability to include the audit trails and metadata in the archive, or a need to preserve the entire original database to allow recreation of the audit trails.	不符合此要求可能导致无法将审计跟踪和元数据包含在归档记录中，或者需要保存整个原始数据库以允许重新创建审计跟踪。	全盘保存挺好的 免得你还得去自己想什么要归档 什么不要归档
There may be business needs that require data to be retained beyond the GxP-mandated retention period; these business needs are discussed in Section 7.4.1.	可能存在业务需求，需要在GxP规定的保存期限之后保留数据；这些业务需求在第7.4.1节中讨论。	N/A
Appendix O4 Tables 16.1 and 16.2 contain examples of retention requirements and periods. Appendix M3 discusses the important considerations around managing data generated by third parties, for example, CROs.	附录O4表16.1和16.2包含保存要求和期限的示例。附录M3讨论了管理第三方（例如CRO）生成数据的重要注意事项。	N/A

火页仔

原文	翻译	感想
Readability	可读性	N/A
Importance of Readability	可读性的重要性	我的天哪 要不是你提醒 我真的都意识不到可读性有多重要！
Data should remain readable during the complete data lifecycle, that is: • Able to be displayed in a human-readable format • For dynamic data, retained in such a way that it can be further interacted with if required by the intended use and/or specific predicate rule requirements (see Section 4.4 on intended use)	在整个数据生命周期中，数据应保持可读状态，即： •能够以人可读格式显示 •对于动态数据，保存方式应能够在预期用途和/或特定的既定规则要求的情况下与之进一步交互（参见第4.4节预期用途）	所以把色谱图打印出来以后 电子图谱就可以删了咩？想想看
With paper records, no special tools are required to read the data.	对于纸质记录，不需要使用专用工具来读取数据。	额 这是为什么？不方便audit？这么一刀切合适吗？
If the paper record has endured (survived), it can be read as a stand-alone complete record.	如果纸质记录已经保存（存续），则可将其视为独立的完整记录。	啥意思？
It can be converted to a static electronic image, that is, a PDF or JPG file by a scanning process, and easily and reliably read on any system having PDF or image viewing software.	它可以通过扫描过程转换为静态电子图像，即PDF或JPG文件，并且在任何具有PDF或图像查看软件的系统上轻松可靠地读取。	这个OK
This should be a verified process to ensure the electronic copy is a true copy, and is discussed in detail in Section 7.2.1.	这应是一个经过验证的过程，以确保电子副本是真实副本，并在第7.2.1节中进行了详细讨论。	很OK 很基操
In a computerized system, original records generated electronically often require additional resources such as databases to supply the record content, along with associated metadata to provide the context and meaning of the record.	在计算机化系统中，电子生成的原始记录通常需要额外的资源，例如数据库来提供记录内容，以及相关的元数据来提供记录的上下文和含义。	N/A
Typically, data created in an electronic system is readable by that same system, and often readable only by that system, due vendor-proprietary formats and database structure.	通常，在电子系统中创建的数据可由同一系统读取，并且由于供应商专有的格式和数据库结构，通常只能由该系统读取。	嗯 确实 但是你想说明啥？
If the record is static in nature (i.e., does not require user intervention or processing to be meaningful), then it can be converted to a PDF or similar format by a verified process to provide ease of readability.	如果记录本质上是静态的（即不需要用户干预或处理才有意义），则可以通过经验证的过程将其转换为PDF或类似格式，以便于阅读。	N/A
Section 7.2.1 discusses the differences between static and dynamic data and implication thereof.	第7.2.1节讨论了静态和动态数据之间的差异及其含义。	N/A

火页仔

原文	翻译	感想
Impact of Upgrades or Retirement on Readability	（系统）升级或停用对可读性的影响	N/A
Changes to the software application such as a software upgrade or database structure modifications can result in a loss of readability for data created in earlier software versions.	软件应用程序变更（例如：软件升级或数据库结构修改）可能会导致早期软件版本中所创建数据的可读性丧失。	这种事情其实就是升级或变更的时候的风险评估中要考虑的
For readability considerations around inactive data stored in a dedicated archiving system, see Section 7.2.2.	关于专用存档系统中存储的非活动数据的可读性考虑，请参见第7.2.2节。	N/A
It is recommended to ensure software is backward compatible prior to the upgrade.	建议在升级之前确保软件向后兼容。	嗯 你也只能是建议了
If the software does not provide backward compatibility, then confirm that the data can be migrated as and when required.	如果软件没有提供向后兼容性，则确认数据可以根据需要迁移。	然后迁移也得验证
Controls around data migration are discussed in Section 3.5.3.	关于数据迁移的控制在第3.5.3节中讨论。	N/A
Changes to a GxP computerized system should be implemented under formal change control and configuration management, which is detailed fully in ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems Chapter 10 [21].	GxP计算机化系统的变更应在正式的变更控制和配置管理下实施，这在ISPE GAMP良好实践指南：基于风险的GxP计算机化系统操作方法第10章中进行了详细说明。	基本要求
When reviewing a change proposal for a computerized system, it is important to review vendor release notes for:	在审查计算机化系统的变更建议时，重要的是审查供应商发布说明中的以下内容：	把这些抄到咱们的风险评估表里去
• Changes to the data structure or file format in the new version, and vendor claims around record compatibility between old and new versions	•新版本中数据结构或文件格式的变更，以及供应商关于新旧版本之间记录兼容性的声明	N/A
Where there will be an impact on the readability of the existing data in applying the software upgrade, remediation activities are needed, such as:	如果应用软件升级会影响现有数据的可读性，则需要进行补救活动，例如：	N/A
Using vendor tools (if provided) to migrate the existing data into a newer format readable by the upgraded software, and verifying the migrated data remains complete (including metadata), accurate, and consistent compared to the original records. Data migration testing, including advice on statistical sampling, is covered in detail in the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) Appendix T9 [22].	使用供应商工具（如果提供）将现有数据迁移到升级后软件可读的较新格式，并确认迁移的数据与原始记录相比保持完整（包括元数据）、准确和一致。ISPE GAMP良好实践指南：基于风险的GxP系统测试方法（第二版）附录T9详细介绍了数据迁移测试，包括统计抽样建议。	很多人问备份恢复，数据迁移的比较测试怎么做，这里有了哦
• If a vendor tool is not available, determine if there is a commercially available tool that can provide the needed data migration.	•如果供应商工具不可用，确定是否有市售工具可以提供所需的数据迁移。	如果供应商工具不可用，市售的能找到的可能性就更低了 so sad
Data migration is discussed in detail in Section 3.5.3.	数据迁移的详细讨论见第3.5.3节。	N/A
Even where there is no explicit vendor statement on the impact to the data readability, it is still recommended to verify that a sample of existing data is readable (and, for dynamic data, can be interacted with) after the upgrade.	即使没有明确的供应商声明对数据可读性的影响，仍建议在升级后确认现有数据的样本是可读的（并且，对于动态数据，可以与之交互）。	我就说嘛 不是所有供应商都那么专业，会考虑到这些东西。 应该说是大部分都不会
Data sampling should be risk-based and leverage statistical approaches to ensure sufficient data is sampled to identify (and correct) any missing or corrupt data.	数据采样应基于风险，并利用统计方法确保采样足够的数据，以识别（并纠正）任何缺失或损坏的数据。	抄你的方法不就好了
This is in addition to, and separate from, validating the change to the computerized system.	这是对计算机化系统变更的验证的补充，并与之分开。	注意 不一定是计算机化系统变更验证的一部分哦 这一部分验证是基于需求的
Where there is an upgrade to a computerized system containing master data (e.g., manufacturing recipes, customer contact details), formal verification may be required to confirm that the data is unaffected and remains aligned across integrated systems.	如果升级的是包含主数据的计算机化系统（例如，生产处方、客户联系方式），可能需要正式确认来保证数据不受影响，并在整个集成系统中保持一致。	啥意思，不包含主数据的系统就不需要正式的确认了？
In the event of a database change, an extensive software upgrade with no migration tool or backward compatibility, or at system retirement, an evaluation should be made of the feasibility of maintaining a functional copy of the original computerized system (either as a physical or virtual machine) that will be used to read and interact with existing data throughout the remaining retention period for that data.	如果数据库发生变更、大量软件升级（无迁移工具或向后兼容性）或系统退役，应评估维护原始计算机化系统（作为物理或虚拟机）功能副本的可行性，该系统将用于在该数据的剩余保留期内读取和与现有数据交互。	另一种思路和做法
Considerations for maintaining functional copies of the software include:	维护软件功能副本的注意事项包括：	N/A
• Newer Operating Systems (OS) have better backward compatibility features that may be able to run legacy software without much trouble if it was produced in the last several years and if the data storage remains in the same structure (e.g., flat file throughout or the same relational database).	•较新的操作系统(OS)具有更好的向后兼容性功能，如果是在过去几年中产生的，如果数据存储保持在相同的结构中（例如，整个过程中的平面文件或相同的关系数据库），则可以在没有太多问题的情况下运行遗留软件。	这也能算是注意事项吗？ 不管怎么样，你都得去确认不是吗
• For laboratory and process control software, it is important to determine if the software application can be run without connection to instrumentation and process equipment.	•对于实验室和过程控制软件，重要的是确定软件应用程序是否可以在不连接仪器和过程设备的情况下运行。	I See
• The practical implications and limitations of maintaining a functional copy of an obsolete system using virtual machine technology, as covered in detail in Appendix O5.	•使用虚拟机技术维护过时系统的功能副本的实际意义和局限性，详见附录O5。	N/A
This should be combined with an assessment of the risk of not keeping the records in a dynamic format (see Section 7.2.1).	这应与不以动态格式保存记录的风险评估相结合（参见第7.2.1节）。	N/A
At some point, as discussed in Section 7.2, maintaining readability of the old dynamic records may become unfeasible and conversion to static format is inevitable.	在某些情况下，如第7.2节所述，保持旧动态记录的可读性可能变得不可行，不可避免地转换为静态格式。	确实啊 这种情况下的风险评估指导很有必要
One risk associated with long-term readability of records is personnel turnover.	与记录的长期可读性相关的一个风险是人员更替。	嗯 这一节还是有很多东西之前没想到过哦
The personnel that generated and interacted with the data may no longer be with the company and operation of the legacy system may be challenging with inexperienced operators.	生成数据或与数据交互的人员可能不在公司了，并且对于没有经验的操作员来说，遗留系统的操作可能具有挑战性。	但是这不应该是人员管理问题吗
It is advisable to archive training materials with the software so there is at least some information available when accessing the old data by inexperienced personnel.	建议将培训材料与软件一起存档，以便在没有经验的人员访问旧数据时至少有一些可用的信息。	人员管理方面也应该做到：不要让公司没有可以执行某项操作的人 每项工作都要有deputy，不说离职了，请假怎么办
Any information that can be provided to a new user about the data also helps the data owner answer questions during a regulatory review.	任何可以提供给新用户的关于数据的信息也有助于数据所有者在监管审查期间回答问题。	N/A

wh_wjy2007

楼主是位爱学习的人才啊；
英文版可上传一个。

小金库

不错，学习了

小胖子和小瘦子

楼主能否分享一下 英文版 原文件
谢谢

zjwhq

楼主没继续了呢？

Junior_KK

Ming- 发表于 2021-9-23 18:06
刚刚离职的前单位领导的委托~~~好绕的关系哦
中文版此前好像坛子见到过，一时没看到连接。顺带文件贴给LZ ...

感谢分享

Junior_KK

biubiua 发表于 2021-9-27 12:05
这部论坛上有人发过中文版，但我找不到原帖了，借花献佛下~不过看楼主的感想超级有意思，还想继续看[face38 ...

感谢分享

13373639166

fantastic!