数据完整性审计之实验室控制

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·Data Integrity Risk assessments should be available for each computerized system identifying any gaps and associated actions taken for their remediation.

·每个计算机化系统都应进行数据完整性风险评估，以识别任何差距并采取相应的补救措施。

·If interim short- term remediation actions are implemented, they should be described and justified and long-term remediation plans should be identified with a target timeline.

·如果实施临时短期补救措施，应对其进行描述和证明，并确定长期补救计划和目标时间表。

·Gauge staff knowledge of Data Integrity when possible.

·在可能的情况下衡量员工的数据完整性知识。

·Determine if all solutionsused in an analytical procedure(e.g. samples, standards) have traceable preparation records

·确定在分析过程中使用的所有溶液(如样品，标准品)是否有可追溯的制备记录

·Cross-check stability testing dates with dates when samples were pulled from chambers. Any late testingshould have proper justification and impact evaluation.

·Cross-check that individuals sign/approve results contemporaneously with the activity. For example are the time intervals duringand between activities realistic?

·Check trash cans and recycle bins in computers. Are records being discarded or deleted?

·交叉检查稳定性测试日期与样品从腔室中提取的日期。任何后期测试都应该有适当的理由和影响评估。

·交叉检查个人在活动进行的同时签署/批准结果。例如，活动期间和活动之间的时间间隔是否真实?

·检查电脑的垃圾桶和回收箱。记录是否被丢弃或删除?

·Check training records on Good Documentation and Data Integrity Practices.

·检查良好文档和数据完整性的培训记录。

o For example, arworks eheets and notebooks locatedin the immediate area to ensure contemporaneous documentation?

例如，工作表和笔记本是否位于临近区域以确保同步的文件记录?

·It is useful to request a list of all notebooks or worksheets issued in the past two years and their status. Ensure that worksheet and laboratory notebook numbers are sequential and controlled, reconciled andarchived.

·请求一份过去两年中发放的所有notebook或工作表及其状态的列表是有用的。确保工作表和实验记录本编号的顺序和控制，核对和归档。

·Any controlled laboratory forms (such as laboratory notebooks and worksheets) must be version controlled including issuance, should be numbered, reconciled, and archived.

·任何受控的实验室表格(如实验室记录本和工作表)必须进行版本控制，包括发放，应编号、核对并存档。

·Documentation procedures should be developed to address, at a minimum:

·制定文件程序，至少要解决以下问题:

oGood Documentation Practices (ALCOA+ principles apply).

良好的文档实践(适用ALCOA+原则)。

oNaming conventions for data.

数据的命名规范。

oControl of folders whereelectronic data are saved. Identifywho has access to name these folders.

控制储存电子资料的文件夹。确定谁有权限命名这些文件夹。

oSystem access controls - see “Security” section 4.3.

系统访问控制-请参阅“安全”章节4.3。

o Data generation including 'test’ injections and their requirements / management and justification (all data should be retained, secured and accounted for).

数据生成，包括“测试”进样及其要求/管理和论证(所有数据应保留、保护和解释)。

oData processing including but not limited to manual integration or other manual processing.

数据处理包括但不限于手动积分或其他手动处理。

o Data review including a defined periodic review of defined audit trails, particularly for “modified” and “deleted” data.Data are to be reviewedin the format in which it is originally collected, thus most laboratory data review will be a review of electronic data unless otherwise justified. Consider that a single description of 'electronic data review” will generally not have sufficient detail so that it can be applied to all systems. Identify critical records and their review frequency.

数据审查包括对已定义的审计跟踪进行定期审查，特别是对“修改”和“删除”的数据。数据应以其最初收集的格式进行审查，因此大多数实验室数据审查将是对电子数据的审查，除非另有理由。考虑到“电子数据审查”的单一描述通常不会有足够的细节以适用于所有系统。识别关键记录及其审核频率。

oData approval should be described and documented either electronically (electronic signature) or using a manual paper based system (e.g., one person performs the review and another person approves the data).

数据批准应以电子方式(电子签名)或使用基于手动纸的系统(例如，一个人执行审查，另一个人批准数据)描述和记录。

·Have data flows diagrams been established for all laboratory equipment and supportive laboratory systems? If not, how have points of risk been identified? Consider the manual or automated transfer of data from an electronic system into a spreadsheet used for calculations and then a transfer back to LIMS or a lab execution system (e.g. NuGenesis (ELN)).Multiple points of risk exist for this type of process.

·是否建立了所有实验室设备和支持性实验室系统的数据流图?如果不是，如何确定风险点?考虑将数据从电子系统手动或自动地转移到用于计算的电子表格中，然后将其转移回LIMS或实验室执行系统(例如NuGenesis (ELN))。这种类型的过程存在多个风险点。

·Data verification and second person review of critical calculations or documenting of raw data for instruments which do not have printoutsor data acquisition systems should ensure verification is occurring contemporaneously.

·对于没有打印输出或数据采集系统的仪器，数据核实和关键计算的第二人审查或原始数据的记录应确保证实同时进行。

· Good Documentation Practices should be evaluated during the laboratory tour.

·Verify the laboratory notebooks follow Good Documentation Practices.

· 良好的文件规范应在实验室参观期间进行评估。

· 验证实验记录本，遵循良好的文档规范。

·Interview QC staff about job functions, investigation processes, data integrity and overall tasks associated with job function and or data generation processing, second person verification, review, and approval.

·就工作职能、调查流程、数据完整性和与工作职能和或数据生成处理相关的总体任务、第二人验证、审查和批准，与QC人员进行面谈。

·Determine if there are systems with shared log-on’s accounts. The use of post-it notes on the back of instruments, or under the keyboard can be suggestive of poor practices. Check the cabinet drawers under the instruments.

·确定是否有共享登录账户的系统。在仪器背面或键盘下使用便利贴可能暗示着不良的做法。检查仪器下面的柜子抽屉。

·Are activities documented at the time they are performed?

·活动在执行时是否有文档记录?

·Are there loose papersin drawers, pocketsor waste containers that contain notes, calculations, or reminders? Are forms or other controlled documents, with or without raw data, found in the general lab area (including trash cans, work stations, or drawers)?

·抽屉里、口袋里或装有便条、计算或提醒的垃圾桶里是否有活页纸?一般实验室区域(包括垃圾桶、工作台或抽屉)是否有表格或其他受控文件(有或没有原始数据)?

·Are analysts located close to their documentation as they work? Are procedures or test methods readily available for the analyst to use and are they used during testing?

·分析师工作时是否离文档很近?是否有现成的程序或测试方法供分析员使用，以及在测试过程中是否使用?

· Does the sample management and data lifecycle reflect the concepts of data integrity? Is there appropriate traceability (e.g., Chain of Custody) of the samples from manufacture, receipt in the laboratory, analytical testing, data processing, review and approval, to the issuance of the CoA captured? Is a program implemented to ensure associated retain samples are taken as appropriate? Is there accountability for destruction of samples?

·样本管理和数据生命周期是否反映了数据完整性的概念?样品从生产、实验室收据、分析测试、数据处理、审核和批准到CoA的签发是否有适当的可追溯性(例如，监管链)?是否实施了程序以确保相关的保留样品被采取适当?销毁样品是否有责任?

·Documentation is completed per ALCOA+ principles in accordance with local QMS procedures in lab notebooks/ documentation with required secondary verification, review, or in an electronic systemsuch as LIMS, that has been validatedensuring the principles of data integrity have been evaluated, with appropriate data authorization by a qualified laboratory person in charge. Procedures describing the review life cycle, roles and responsibilities should be implemented and trained

on by the appropriate laboratory personnel.

·根据ALCOA+原则，按照当地的质量管理程序，在实验室记录本/文件中完成文件，并进行必要的二次验证，审查，或在电子系统中完成，如LIMS，该系统已经过验证，确保数据完整性原则已经过评估，并由合格的实验室负责人进行适当的数据授权。应实施和培训描述评审生命周期、角色和职责的程序由适当的实验室人员负责。

·The list of GMP computerized systems should include all GMP laboratory computer systems as noted in Section 4.

·GMP计算机系统清单应包括第4节中提到的所有GMP实验室计算机系统。

·Are there any systems in the laboratory where data is manually or automatically transferred between systems? What controls are in place to mitigate any data integrity issues? This includes the situations where data may be manually transferred from an electronic systemto a spreadsheet for purposesof calculations and then hand entered into LIMS. Verification or validation of the data transfer process should be tested and completed.

·实验室中是否有系统可以手动或自动地在系统之间传输数据?采取了哪些控制措施来缓解数据完整性问题?这包括数据从电子系统手动传输到电子表格以进行计算，然后手工输入LIMS的情况。数据传输过程的验证或确认应经过测试和完成。