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Guideline for Excel spreadsheet validation Excel电子表格验证指南 March 13, 2025 Excel spreadsheet validation involves developing and testing spreadsheet applications and confirming that the information generated through the spreadsheet is accurate, complete, intended, and reproducible. Excel电子表格验证涉及开发和测试电子表格应用程序，并确认通过电子表格生成的信息准确、完整、预期的且可重现。 While working in a GMP facility, I had to use many Excel spreadsheets developed with formulas, macros, and many other functions. 在GMP设施工作时，我不得不使用许多通过公式、宏和许多其他函数开发的Excel电子表格。 As I entered raw data, these spreadsheets processed it and generated useful information. I relied on the accuracy of that information to decide whether to accept or reject a pharmaceutical batch. 当我输入原始数据时，这些电子表格会对其进行处理并生成有用的信息。我依靠这些信息的准确性来决定是接受还是拒绝一批药品。 We had to ensure that those Excel spreadsheets were processing GMP data accurately and reproducibly so that our decision did not adversely affect the patient’s health. 我们必须确保这些Excel电子表格准确且可重复地处理 GMP 数据，以便我们的决定不会对患者的健康造成不利影响。 This article will provide a practical framework and approach for the Excel spreadsheet validation used in direct or indirect GMP-related activities, empowering you in your decision-making process. 本文将为直接或间接 GMP 相关活动中使用的Excel电子表格验证提供实用的框架和方法，帮助您做出决策。 We will show how to validate Excel spreadsheets designed and used for making decisions in GMP environments, which directly impact product quality, safety, and identity of medicinal products. 我们将展示如何验证在GMP环境中设计和用于决策的Excel电子表格，这直接影响药品的质量、安全性和特性。 Key Takeaways 关键要点·Validating Excel spreadsheets ensures that they provide accurate, consistent, and complete information. Accuracy and reliability are essential in GMP environments where spreadsheet data directly influences product quality and patient safety. 验证Excel电子表格可确保其提供的信息准确、一致且完整。准确性和可靠性在 GMP 环境中至关重要，因为电子表格数据直接影响产品质量和患者安全。 ·Validation must comply with frameworks like GAMP, which categorizes spreadsheets based on their complexity. Excel spreadsheets are categorized between GAMP 3 and 5 for validation requirements. GAMP 3 requires less rigorous validation than GAMP 5, which involves complex features like macros and sophisticated formulas. 验证必须符合GAMP等的框架，该框架根据电子表格的复杂程度对其进行分类。Excel电子表格的验证要求分为GAMP 3和5两类。GAMP 3类的验证要求不如GAMP 5类严格，因为 GAMP 5类涉及宏和复杂公式等复杂功能。 ·The validation process includes developing functional requirements, creating the spreadsheet, and conducting thorough qualification testing. This ensures that the spreadsheet functions correctly and meets all specified requirements. 验证过程包括开发功能需求、创建电子表格以及进行全面的确认测试。这可确保电子表格正常运行并满足所有指定需求。 ·Essential tests during validation include verifying calculations, logical functions, data handling under extreme conditions, performance with large datasets, error handling, and integration with external systems. Each test helps confirm that the spreadsheet performs reliably and accurately. 验证期间的必要测试包括验证计算、逻辑函数、极端条件下的数据处理、大型数据集的性能、错误处理以及与外部系统的集成。每项测试都有助于确认电子表格的运行是否可靠且准确。 ·To maintain the integrity of validated spreadsheets, it is important to control access, train users, and store these records appropriately. Regular re-validation is required to ensure ongoing compliance and effectiveness. 为了保持已验证电子表格的完整性，控制访问权限、培训用户并适当存储这些记录非常重要。需要定期再验证以确保持续合规性和有效性。 ·If validation tests reveal issues, document them, perform a root cause analysis, implement corrective actions, and update the validation protocol as needed. Re-testing ensures that all problems are resolved. 如果验证测试发现问题，请记录这些问题，进行根本原因分析，实施纠正措施，并根据需要更新验证方案。重新测试可确保所有问题都得到解决。 Why is Excel spreadsheet validation required? 为什么需要Excel电子表格验证？Excel spreadsheets are widely used in pharmaceutical operations, from simple data entry in the registers to complex data processing using functions and formulas. Excel电子表格广泛应用于制药业务，从登记册中的简单数据输入，到使用函数和公式的复杂数据处理。 Excel spreadsheet offers many functions to make our lives easy. We use statistical and mathematical functions routinely. Some of those are ingrained in our minds, such as auto-sum or showing the median, mode, average, range, trend, standard deviations, etc. Excel电子表格提供许多功能，让我们的生活更轻松。我们经常使用统计和数学函数。其中一些已经根深蒂固地印在我们的脑海中，例如自动求和或显示中位数、众数、平均值、范围、趋势、标准差等。 Inside an Excel spreadsheet, you can create Lookup functions such as 'Vlookup,’ 'Hlookup,’ and 'And Index,’ or create logical functions like If, And, Or, Not, etc., to generate useful information from the initial data points. 在Excel电子表格中，您可以创建查找函数，例如“Vlookup”、“Hlookup”和“And Index”，或者创建逻辑函数，例如 If、And、Or、Not 等，以从初始数据点生成有用的信息。 You can also create macros, conditional formatting, data validation, pivot tables, and many other features as a handy tool for presenting data. 您还可以创建宏、条件格式、数据验证、数据透视表和许多其他功能，作为呈现数据的便捷工具。 When Excel spreadsheets facilitate our decision-making on product quality, it is critical to validate them to ensure the information is accurate, consistent, complete, and true. 当Excel电子表格帮助我们做出有关产品质量的决策时，验证它们以确保信息准确、一致、完整和真实至关重要。 Accuracy is crucial to guarantee the data entered and the calculations performed are correct. 准确性对于保证输入的数据和执行的计算正确性至关重要。 Any inaccuracy in the formula can lead to incorrect conclusions, severely affecting product quality. 公式中的任何不准确都可能导致错误的结论，严重影响产品质量。 The results generated through Excel spreadsheets must be consistent. Consistency ensures that data and calculations are uniform across the spreadsheet. 通过Excel电子表格生成的结果必须一致。一致性可确保整个电子表格中的数据和计算是统一的。 For example, if a column is programmed to generate results based on the data from two other columns, this calculation should be consistently applied across all rows. 例如，如果对某一列进行编程以根据来自另外两列的数据生成结果，则该计算应一致地应用于所有的行。 Data integrity ensures the relationships between different data sets within the spreadsheet are preserved. For example, if a column references values in another column, all the referenced values should exist. 数据完整性确保电子表格中不同数据集之间的关系得以保留。例如，如果一列引用另一列中的值，则所有引用的值都应该存在。 Lastly, data trustworthiness is also critical to complying with regulatory requirements. Validated data is more reliable and can be trusted to make informed decisions. 最后，数据的可靠性对于遵守监管要求也至关重要。经过验证的数据更可靠，可以信赖它来做出明智的决策。 Regulatory requirements for Excel spreadsheet validation Excel电子表格验证的监管要求Many of us regularly use Excel spreadsheets to record and manipulate GMP data (i.e., change, delete, add). Therefore, it is necessary to manage these spreadsheets to ensure the data’s continued integrity and security. 我们许多人经常使用Excel电子表格来记录和操作 GMP 数据（即更改、删除、添加）。因此，有必要管理这些电子表格以确保数据的持续完整性和安全性。 While some spreadsheets are no more than fancy calculators, others are embedded with special features and use intricate logic in Macros, which are, in effect, computer programs. 虽然有些电子表格只不过是花哨的计算器，但有些电子表格嵌入了特殊功能并使用宏中的复杂逻辑，而宏实际上就是计算机程序。 Good Automated Manufacturing Practice (GAMP) by ISPE provides a detailed framework for Excel spreadsheet validation, which is primarily adopted by international regulatory authorities. ISPE 的良好自动化生产规范 (GAMP) 为Excel电子表格验证提供了详细的框架，主要被国际监管机构采用。 Excel spreadsheets can be classified into GAMP categories depending on their use and contents. Excel电子表格可根据其用途和内容分为 GAMP 类别。 GAMP categorization dictates the level of applicable qualification and validation effort, just as with other computerized systems. 与其他计算机化系统一样，GAMP 分类规定了适用的确认和验证工作的水平。 Below are the GAMP categories commonly interpreted for spreadsheets. 以下是电子表格中常用的 GAMP 类别。 Spreadsheets with different levels of GAMP category 具有不同级别 GAMP 类别的电子表格GAMP 3: These spreadsheets are used solely to produce paper documents. GAMP 3：这些电子表格仅用于产生纸质文档。 GAMP 4: These spreadsheets are more complex, such as those used as templates that incorporate process steps. GAMP 4：这些电子表格更为复杂，例如用作包含流程步骤的模板的电子表格。 GAMP 5: These spreadsheets use macros, lookup tables &/or sophisticated logic, etc. GAMP 5：这些电子表格使用宏、查找表和/或复杂逻辑等。 Spreadsheets that fall into GAMP category 3 guidelines do not require full validation activities but should be held under appropriate security conditions. 符合 GAMP 类别 3 指南的电子表格不需要进行完整的验证活动，但应在适当的安全条件下保存。 Spreadsheets with calculations fully explained on the spreadsheet that undergo verification with each use do not need to be fully validated. 在电子表格上充分解释计算的电子表格，每次使用时都要经过确证，不需要完全验证 Spreadsheets that fall into GAMP category 5, having complex formulas, macros, lookup tables, or sophisticated functions and logic, will require complete data validation effort to ensure these spreadsheets generate results free from error and bias. 属于 GAMP 类别 5 的电子表格具有复杂的公式、宏、查找表或复杂的函数和逻辑，需要完整的数据验证工作以确保这些电子表格生成的结果没有错误和偏差。 Where spreadsheets are used as templates, you should maintain appropriate security conditions, including password protection and secure storage. 当使用电子表格作为模板时，您应该维护适当的安全条件，包括密码保护和安全存储。 How do you plan for Excel spreadsheet validation? 您如何规划Excel电子表格验证？When you plan to validate a complex Excel spreadsheet, you must follow a framework similar to those used in computer system validation. 当您计划验证复杂的Excel电子表格时，您必须遵循与计算机系统验证中使用的框架类似的框架。 However, the validation scope is much narrower and specific to spreadsheet development and use. 然而，验证范围要窄得多，并且特定于电子表格的开发和使用。 Step 1: Develop functional requirements of Excel spreadsheet 步骤1：制定Excel电子表格的功能需求An Excel spreadsheet’s functional requirements are prepared considering user requirements and functional specifications. The developer should write the functional requirements. Excel电子表格的功能需求是根据用户需求和功能规范制定的。开发人员应该编写功能需求。 The functional requirements should be approved before the initial design of the Excel spreadsheet. 在Excel电子表格的初始设计之前，应该批准功能需求。 Functional requirements can also be developed retrospectively after a prototype spreadsheet has been prepared. 在准备好原型电子表格后，还可以回顾性地开发功能需求。 The functional requirements document should contain the following areas: 功能需求文档应包含以下区域： -The purpose of the spreadsheet application (such as calculating results, re-ordering results for management reports, etc.). 电子表格应用程序的用途（例如计算结果、重新排序管理报告的结果等）。 -The formulas included in the spreadsheet application, including logical formulas used for branching or calculations. 电子表格应用程序中包含的公式，包括用于分支或计算的逻辑公式。 -A description of macros that will be included. 将包含的宏的描述。 -A description of any column or row rearrangements/sorting required to format a new report from included data. 对根据所包含数据格式化新报告所需的任何列或行重新排列/排序的描述。 -A description of the report that will be generated. 将生成的报告的描述。 -A statement defining electronic storage requirements for the executed spreadsheet -application (results). 定义已执行的电子表格应用程序（结果）的电子存储要求的声明。 -Where applicable, issues such as data formats and numerical precision, numeric rules such as rounding or floating points, flagging of limits, boundary conditions, filters, or outliers. 在适用的情况下，数据格式和数值精度等问题，数字规则（例如四舍五入或浮点）、限制标记、边界条件、过滤器或异常值。 -Performance requirements for the application and program (i.e., calculations or reports within 'X’ seconds, applications/program availability, etc.). 应用程序和程序的性能要求（即'X’秒内的计算或报告、应用程序/程序可用性等）。 -Workflow needs such as the source of the data, a statement regarding raw data, and “who will perform what actions and make what decisions based on what data and criteria” may be required. 可能需要工作流程需求，例如数据来源、有关原始数据的声明以及“谁将执行哪些操作以及根据哪些数据和标准做出哪些决策”。 Step 2: Develop the Excel spreadsheet application 步骤2：开发Excel电子表格应用程序Sometimes, internal employees (e.g., Senior laboratory analysts) are responsible for developing spreadsheet applications. 有时，内部员工（例如高级实验室分析师）负责开发电子表格应用程序。 However, you should make sure that the employees are adequately trained and qualified to work with Excel spreadsheets. 但是，您应该确保员工经过充分培训，有资格使用Excel电子表格。 Could you make sure the employees know the internal work process, which should be correctly reflected in the new application? 您能否确保员工了解内部工作流程，并正确反映在新的应用程序中？ The developer should be able to devise the spreadsheet parameters, such as how the table should look, data formats, data sorting parameters, adding fields to the spreadsheet, reports, formulas, and interfaces with other programs and instrumentation. 开发人员应该能够设计电子表格参数，例如表格的外观、数据格式、数据排序参数、向电子表格添加字段、报告、公式以及与其他程序和仪器的接口。 i. Consider how raw data will be entered into the spreadsheet 考虑如何将原始数据输入电子表格The spreadsheet developer must define how raw data will be entered. 电子表格开发人员必须定义如何输入原始数据。 Data can be fed directly into a spreadsheet from adjoining instruments, or data can be entered manually. 数据可以从相邻的仪器直接输入到电子表格中，也可以手动输入数据。 Raw data will be fed directly from the instrument to the spreadsheet application through the digital interface for automated operations. 原始数据将通过数字接口从仪器直接输入到电子表格应用程序，实现自动化操作。 If data sets are entered manually, a second individual must review all entered data to verify the correctness. 如果手动输入数据集，则必须由第二个人检查所有输入的数据以验证正确性。 The initials of the reviewer and the date of review should be indicated. 应注明审稿人的姓名首字母和审稿日期。 The transfer link between the spreadsheet application and the data source must be validated if data sets are entered automatically through an electronic interface. 如果通过电子界面自动输入数据集，则必须验证电子表格应用程序和数据源之间的传输链接。 On the other hand, data from a spreadsheet must only be exported to a validated computer system or application if the transfer link has been validated and the importation process is approved via change control for the receiving system. 另一方面，仅当传输链接已经过验证且导入过程已通过接收系统的变更控制批准后，电子表格中的数据才可以导出到经过验证的计算机系统或应用程序。 ii. Develop necessary formulas in the spreadsheet 在电子表格中制定必要的公式Each formula described in the requirements documents must be embedded in the spreadsheet application. 需求文档中描述的每个公式都必须嵌入电子表格应用程序中。 The formulas must be checked for errors during development. 在开发过程中必须检查公式是否有错误。 Diagnostic tools that allow error checking during development are sometimes available with spreadsheet programs. 电子表格程序有时提供允许在开发过程中检查错误的诊断工具。 Examples of error detection tools include: 错误检测工具的示例包括： –Cell error messages that are created when cell rules are violated 当违反单元格规则时创建的单元格错误消息 –Cells referred to by a formula in another cell may be audited for alignment, with the spreadsheet displaying tracer arrows between cells. 可以审核另一个单元格中公式引用的单元格是否对齐，电子表格会在单元格之间显示追踪箭头。 –When a formula returns an error, another auditing tool can be used to track it back to its source. This tool is sometimes called an error tracer. 当公式返回错误时，可以使用另一个审计工具来追踪其来源。此工具有时称为错误追踪器。
Excel formula example Excel 公式示例 iii. Rearrange the spreadsheet columns and rows 重新排列电子表格的列和行Spreadsheets are also used to sort and rearrange data for reports and presentations. 电子表格还用于对报告和演示文稿的数据进行排序和重新排列。 Spreadsheets are not limited to a single source of data. They can handle information from various programs, databases, and even instrument systems, such as reporting data from a chromatographic software system. 电子表格并不局限于单一的数据源。它们可以处理来自各种程序、数据库甚至仪器系统的信息，例如来自色谱软件系统的报告数据。 I’d like you to describe the procedures for sorting or rearranging the data using the spreadsheet application. 我希望您描述使用电子表格应用程序对数据进行排序或重新排列的过程。 iv. Program of Macro within the Excel spreadsheet Excel电子表格中的宏程序One of the most powerful features of Excel is the ability to automate repetitive tasks. Excel 最强大的功能之一是能够自动执行重复任务。 By recording these tasks as macros, you can play them back whenever necessary, saving you time and effort. 通过将这些任务记录为宏，您可以在必要时播放它们，从而节省时间和精力。 Macros may be associated with toolbar buttons, keystrokes, and menu entries. 宏可能与工具栏按钮、按键和菜单项相关联。 Manual sorting and rearranging of data are actions that might be automated. Still, if the macro is recorded, the actions must be carefully documented during development and tested during the qualification process. 手动排序和重新排列数据是可以自动化的操作。但是，如果录制了宏，则必须在开发过程中仔细记录这些操作，并在确认过程中进行测试。
Excel marcos example Excel宏示例 v. Generate reports from the spreadsheet 从电子表格生成报告As the developer, your crucial role is to create or modify the spreadsheet. This is essential for generating automated reports, which are based on the calculations performed by the spreadsheet application. 作为开发人员，您的关键角色是创建或修改电子表格。这对于生成基于电子表格应用程序执行的计算的自动报告至关重要。 A typical report from the spreadsheet may contain some of the following attributes but are not limited to: 电子表格中的典型报告可能包含以下一些属性，但不限于： –The method (i.e., Laboratory Analytical) used during data creation. 数据创建过程中使用的方法（即实验室分析）。 –A unique identifier for the analyst and the checker responsible for the correctness of entries into the spreadsheet application. 负责电子表格应用程序输入正确性的分析师和检查员的唯一标识符。 –The date the spreadsheet application was executed. 电子表格应用程序的执行日期。 –The version of the spreadsheet application program. 电子表格应用程序的版本。 –Version control for the report. 报告的版本控制。 –The unique name of the electronic version of the file. 文件电子版本的唯一名称。 When data is received through an electronic interface, the report must identify the instrument system or software program that communicated the data. 当通过电子接口接收数据时，报告必须识别传输数据的仪器系统或软件程序。 This information is necessary for comprehensive reporting. 这些信息对于综合报告而言是必需的。 Step 3: Qualifications for Excel spreadsheet validation 步骤3：Excel电子表格验证确认After you develop the spreadsheet, the file will be transferred to the validation team for qualification testing. 开发电子表格后，该文件将被传送给验证团队进行确认测试。 The validation engineer must prepare qualification test protocols for installation, operational, and performance qualifications. 验证工程师必须为安装、运行和性能确认制定确认测试方案。 i. Installation qualification of Excel spreadsheet Excel电子表格的安装确认Installation qualification (IQ) will provide documented evidence that the Excel spreadsheet has been designed, developed, supplied, and installed following user requirements and functional specifications. 安装确认 (IQ) 将提供书面证据，证明Excel电子表格是按照用户要求和功能规范设计、开发、提供和安装的。 The installation qualification tests aim to demonstrate that all the Excel spreadsheet’s primary features are available as designed. 安装确认测试旨在证明Excel电子表格的所有主要功能均按设计可用。 The equipment is one step closer to satisfactory operation. 该设备距离令人满意的运行又近了一步。 The IQ test protocol will include the spreadsheet name, version number, location, and access control. During the initial installation of the secure directory, implement appropriate security restrictions. IQ 测试方案将包括电子表格名称、版本号、位置和访问控制。在安全目录的初始安装期间，实施适当的安全限制。 The validation team needs to store a master copy of the spreadsheet in a secure environment. 验证团队需要将电子表格的主副本存储在安全的环境中。 Each time the spreadsheet is required for use on a computer in the user area, it must be opened from the read-only master copy. 每次需要在用户区域计算机上使用电子表格时，都必须从只读主副本中打开它。 Lock cells containing formulas to protect their contents. Protect the spreadsheet with a password. Maintain the access control information (including the passwords) securely. 锁定包含公式的单元格以保护其内容。使用密码保护电子表格。安全地维护访问控制信息（包括密码）。 Successful installation qualification will help you achieve the following: 成功的安装确认将帮助您实现以下目标： –Verify that all necessary features, add-ins, or extensions are installed and operational. 确证所有必要的功能、插件或扩展均已安装并可运行。 –The spreadsheet is compatible with the memory, storage, processing speed, and other necessary hardware components. 电子表格与内存、存储、处理速度和其他必要的硬件组件兼容。 –Verification that the network configurations are correct if the spreadsheet needs to access remote data or if multiple users need to collaborate on the same document 如果电子表格需要访问远程数据或多个用户需要在同一文档上进行协作，则验证网络配置是否正确 –Ensure that only authorized users can access the spreadsheet. Please verify that data is encrypted and that an audit trail is active. 确保只有授权用户才能访问电子表格。请验证数据是否已加密并且审计追踪是否处于活动状态。 –Ensures that there are systems in place to back up the spreadsheet and recover data in case of any failures 确保有系统备份电子表格并在发生任何故障时恢复数据 ii. Operation qualifications of Excel spreadsheet Excel表格的运行确认The operational qualification (OQ) will confirm that the correctly installed spreadsheet can operate repeatedly according to its functional specifications. 运行确认（OQ）将确认正确安装的电子表格能够按照其功能规格重复运行。 An Excel spreadsheet’s operational qualification (OQ) includes the following tests. Excel电子表格的运行确认 (OQ) 包括以下测试。 You should establish acceptance criteria for each test and write it into the operation qualification protocol. 您应该为每个测试建立可接受标准并将其写入运行确认方案中。 1. Calculation test or functional test 计算试验或功能试验Calculation tests are performed to verify that correct formulas, macros, and functions are entered. 进行计算测试以确证输入的公式、宏和函数是否正确。 Enter sample values in all fields included in the input range of all mathematical functions. 在所有数学函数的输入范围内的所有字段中输入样本值。 Use different values for each field to restrict the input to whole numbers for aggregate functions (sum, max, etc.). 对每个字段使用不同的值，以将聚合函数（总和、最大值等）的输入限制为整数。 The tests also verify the data input mechanisms (e.g., dropdown lists and data validation rules) are functioning correctly. 测试还确证数据输入机制（例如，下拉列表和数据验证规则）是否正常运行。 Any visualization aids, such as charts, graphs, etc., are rendered correctly and updated with data changes. 任何可视化辅助工具，如图表、图形等，都能正确呈现并随着数据的变化而更新。 Please document the step, include a printout of the spreadsheet indicating the test values, and compare the printout to that obtained from a calculator. 请记录该步骤，附上标明测试值的电子表格的打印输出，并将打印输出与计算器获得的值进行比较。 Acceptance criteria for functional tests 功能测试的可接受标准 Calculated values from the spreadsheet application must be identical to those obtained from a calculator (preferably with printout capabilities). 电子表格应用程序计算出的值必须与计算器（最好具有打印输出功能）获得的值相同。 2. Logical values test 逻辑值测试Logical values tests are performed to verify Boolean algebra formulas. 执行逻辑值测试来验证布尔代数公式。 Logical values often refer to conditions that are evaluated as TRUE or FALSE. 逻辑值通常指评估为 TRUE 或 FALSE 的条件。 In the context of Excel spreadsheets validation, you might be testing cells or formulas that rely on logical functions (like IF, AND, OR) to see if they produce the expected results under various scenarios, including extreme or boundary conditions. 在Excel电子表格验证中，您可能正在测试依赖于逻辑函数（如 IF、AND、OR）的单元格或公式，以查看它们是否在各种场景（包括极端或边界条件）下产生预期结果。 Print the spreadsheet cells containing Boolean (logical values) and calculate the results manually. Print the results from the spreadsheet application calculation. 打印包含布尔值（逻辑值）的电子表格单元格并手动计算结果。打印电子表格应用程序计算的结果。 Acceptance criteria for logical value tests 逻辑值测试的可接受标准 For logical values (e.g., Pass/Fail or True/False), verify the displayed value is the same as the expected value, calculated manually. 对于逻辑值（例如，通过/失败或真/假），验证显示的值是否与手动计算的预期值相同。 3. Range/precision test 范围/精度测试Range/precision tests are performed to verify calculations will still be accurate when extremely large or small values are entered. 进行范围/精度测试是为了验证当输入极大或极小的值时计算仍然准确。 Enter extremely large values at the correct precision (e.g., enter 99.99 for 0.01 precision). 以正确的精度输入极大的值（例如，对于 0.01 精度，输入 99.99）。 For aggregate functions, enter 0 in one or more fields with non-zero values in other fields. 对于聚合函数，在一个或多个字段中输入 0，并在其他字段中输入非零值。 Could you duplicate the formula calculations using a calculator and compare the results/printouts? 您能否使用计算器重复公式计算并比较结果/打印输出？ Repeat this test with extremely small values and report the results. 用极小的值重复此测试并报告结果。 Acceptance criteria for precision tests精度测试的可接受标准 Calculated values from the spreadsheet application must be identical to those calculated manually using a calculator (with correct precision and consistent with the agreed rounding principle). 电子表格应用程序计算出的值必须与使用计算器手动计算的值相同（具有正确的精度并符合商定的舍入原则）。 4. Challenge condition (boundary and extreme condition) test 挑战条件（边界和极端条件）测试The challenge condition test is also called the Boundary and Extreme Condition Testing. 挑战条件测试也称为边界与极端条件测试。 The test involves inputting values at the extreme ends of expected ranges to ensure the spreadsheet handles them appropriately. 测试涉及输入预期范围极值以确保电子表格能够适当地处理它们。 For instance, if a cell expects a value between 1 and 100, what happens if you input 0, 101, or a text string? 例如，如果一个单元格需要一个介于 1 和 100 之间的值，那么输入 0、101 或文本字符串会发生什么情况？ The challenge condition test can help detect errors in formulas or functions that might not be evident under regular conditions. 挑战条件测试可以帮助检测在常规条件下可能不明显的公式或函数中的错误。 Acceptance criteria for challenge condition 挑战条件的可接受标准 The spreadsheet should either correctly process boundary and extreme inputs or produce appropriate error messages. 电子表格应该正确处理边界和极端输入，或者产生适当的错误消息。 No crashes or unintended behaviors should occur when such values are entered. 输入此类值时不应发生崩溃或意外行为。 5. Performance test 性能测试Suppose your spreadsheet is required to handle large datasets. In that case, it’s essential to check its performance to ensure that calculations, data processing, or visualizations stay consistent and prevent the software from crashing. 假设您的电子表格需要处理大型数据集。在这种情况下，检查其性能至关重要，以确保计算、数据处理或可视化保持一致并防止软件崩溃。 Acceptance criteria for performance test 性能测试可接受标准 For large datasets or complex calculations, the spreadsheet should complete tasks within an acceptable timeframe (e.g., recalculations or data processing should be completed within 10 seconds). The software should not crash or freeze during these operations. 对于大型数据集或复杂计算，电子表格应在可接受的时间范围内完成任务（例如，重新计算或数据处理应在 10 秒内完成）。软件在这些运行期间不应崩溃或冻结。 6. Error handling and recovery test 错误处理和恢复测试Error handling and recovery test involves introducing intentional errors to see how the spreadsheet responds. 错误处理和恢复测试涉及引入故意错误以查看电子表格如何响应。 For example, what happens if a required input is left blank? 例如，如果必填输入留空会发生什么情况？ It’s essential to check if appropriate error messages are displayed and if the spreadsheet can recover without data loss or corruption. 检查是否显示适当的错误消息以及电子表格是否可以恢复而不会丢失或损坏数据至关重要。 Acceptance criteria error handling test 错误处理测试的可接受标准 When intentional errors occur, the spreadsheet should either manage them gracefully (e.g., by substituting a default value) or provide a clear error message. 当发生故意错误时，电子表格应该妥善管理它们（例如，通过替换默认值）或提供清晰的错误消息。 No data corruption should occur due to these errors. 这些错误不应导致任何数据损坏。 7. Integration and interface test 集成及接口测试If your spreadsheet pulls data from external sources, databases, or other software, it’s essential to verify that these integrations work correctly. 如果您的电子表格从外部来源、数据库或其他软件提取数据，则必须确证这些集成是否正常工作。 This involves checking the accuracy of imported data and ensuring timely data refreshes. 这涉及检查导入数据的准确性并确保及时更新数据。 Acceptance criteria for integration and interface test 集成和接口测试的可接受标准 Data imported from external sources should match the source data wholly and accurately. 从外部来源导入的数据应与源数据完整、准确匹配。 There should be no errors or significant delays during data imports/refreshes. 数据导入/刷新期间不应出现错误或明显延迟。 8. Audit trail and version control test 审计追踪和版本控制测试Since your spreadsheets will be used in regulated environments such as GMP, it is necessary to ensure a robust audit trail is implemented for the Excel spreadsheets. 由于您的电子表格将在 GMP 等受监管环境中使用，因此必须确保为Excel电子表格实施强大的审计追踪。 The audit trail and version control test verify that changes, edits, or deletions are appropriately logged and that a traceable history of spreadsheet versions is maintained. 审计追踪和版本控制测试验证是否适当记录了更改、编辑或删除，并维护了电子表格版本的可追溯历史记录。 Acceptance criteria for audit trail 审计追踪的可接受标准 All changes, edits, or deletions should be logged with a timestamp, user ID, and a change description. 所有更改、编辑或删除都应记录时间戳、用户 ID 和更改描述。 Previous versions of the spreadsheet should be retrievable, and changes between versions should be traceable. 电子表格的先前版本应该是可检索的，并且版本之间的变化应该是可追踪的。 9. Backup and restoration test 备份与恢复测试The backup and restoration test involves intentionally deleting or corrupting the spreadsheet and trying to restore it from backups to ensure that backup mechanisms are effective. 备份和恢复测试包括故意删除或破坏电子表格并尝试从备份中恢复它，以确保备份机制有效。 Acceptance criteria for backup test 备份测试的可接受标准 After intentional deletion or corruption, the spreadsheet should be fully restorable from backups. 在故意删除或损坏后，电子表格应该可以从备份中完全恢复。 Restored data should match the original data wholly and accurately without any loss. 恢复的数据应与原始数据完全准确匹配，不得有任何损失。 iii. Performance qualification of Excel spreadsheet Excel电子表格的性能确认Performance qualification (PQ) during Excel spreadsheet validation ensures that the tool consistently delivers accurate results in real-world scenarios. Excel电子表格验证期间的性能确认 (PQ) 可确保该工具在实际场景中始终提供准确的结果。 By testing under actual user conditions and with genuine data sets, PQ validates that the spreadsheet meets theoretical specifications and performs reliably in daily operations. 通过在实际用户条件下和使用真实数据集进行测试，PQ 验证电子表格是否符合理论规范并在日常运行中可靠运行。 iii. Performance qualification (PQ) confirms that the spreadsheet fits its intended purpose. 性能确认 (PQ) 确认电子表格符合其预期用途。 Following is a list of performance qualification tests you may try, including the acceptance criteria. 以下是您可以尝试的性能确认测试列表，包括可接受标准。 1. End-user operation test 最终用户运行测试The end-user operation test verifies that the spreadsheet performs as expected when used by its intended users. 最终用户运行测试验证电子表格在由预期用户使用时是否能按预期运行。 This would involve typical day-to-day tasks, such as data entry, calculations, generating reports, or any other regular function the spreadsheet is intended for. 这将涉及典型的日常任务，例如数据输入、计算、生成报告或电子表格所需的任何其他常规功能。 Acceptance criteria 可接受标准 The spreadsheet must complete all standard operational tasks (e.g., calculations, report generation) without errors within defined time frames when end-users operate. 当最终用户运行时，电子表格必须在规定的时间范围内准确无误地完成所有标准运行任务（例如，计算、报告生成）。 2. Long-term stability and performance test 长期稳定性及性能测试This test verifies how the spreadsheet behaves with prolonged use. 此测试验证电子表格在长期使用后的表现。 If data is added to the spreadsheet over time, does it continue to perform well, or do issues arise as it becomes more populated? 如果随着时间的推移数据添加到电子表格中，它是否能继续表现良好，或者是否会出现随着数据变得越来越多而出现的问题？ Acceptance criteria 可接受标准 The spreadsheet should maintain consistent performance levels over an extended period (e.g., six months) without showing signs of lag, crashes, or errors even as data accumulates. 电子表格应该在较长的一段时间内（例如六个月）保持一致的性能水平，即使数据积累，也不会出现滞后、崩溃或错误的迹象。 3. Real-world data test 真实世界数据测试This test involves entering actual, real-world data sets in the spreadsheet rather than test or synthetic data. This ensures that it can handle the nuances and complexities of genuine data. 该测试涉及在电子表格中输入实际的现实世界数据集，而不是测试或合成数据。这确保它可以处理真实数据的细微差别和复杂性。 Acceptance criteria 可接受标准 The spreadsheet should correctly process and display real-world data sets, maintaining data integrity and producing expected outputs or results. 电子表格应该正确处理和显示真实世界的数据集，保持数据完整性并产生预期的输出或结果。 4. Scalability test 可扩展性测试The scalability test checks how the spreadsheet performs as data grows. 可扩展性测试检查电子表格在数据增长时的表现。 This applies to spreadsheets that are expected to handle increasing amounts of data over time; ensuring that performance doesn’t degrade is vital. 这适用于预计随着时间的推移处理越来越多数据的电子表格；确保性能不下降至关重要。 Acceptance criteria 可接受标准 The spreadsheet should not crash, freeze, or significantly slow down as data volume or complexity increases to the maximum expected level. 当数据量或复杂性增加到预期的最大水平时，电子表格不应该崩溃、冻结或显著减速。 Calculations or data manipulations should still be completed within acceptable time frames. 计算或数据处理仍应在可接受的时间范围内完成。 5. Environmental conditions test 环境条件测试While this test is not common for standard office environments, the environment test is critical in certain scenarios. 虽然这种测试在标准办公环境中并不常见，但在某些情况下环境测试至关重要。 For example, if the spreadsheet is used in manufacturing environments with the potential for network interruptions or power fluctuations, how does the spreadsheet behave? 例如，如果电子表格用于可能出现网络中断或电源波动的制造环境中，电子表格会如何表现？ Acceptance criteria 可接受标准 The spreadsheet should maintain consistent performance and data integrity under varying environmental conditions, such as network fluctuations or power interruptions. 电子表格应在不同的环境条件下（例如网络波动或电源中断）保持一致的性能和数据完整性。 Any auto-save or recovery features should work as intended. 任何自动保存或恢复功能都应按预期工作。 6. User acceptance test 用户验收测试Users work with the spreadsheet during this test to ensure it meets their needs and expectations. 用户在测试期间使用电子表格以确保其满足他们的需求和期望。 Feedback from these users can provide valuable insights into potential improvements or adjustments. 这些用户的反馈可以为潜在的改进或调整提供宝贵的见解。 Acceptance criteria 可接受标准 End-users should confirm that the spreadsheet meets or exceeds their operational needs. There should be no critical feedback points that would hinder the regular use of the spreadsheet in its intended environment. 最终用户应确认电子表格满足或超出其运营需求。不应存在任何会妨碍电子表格在预期环境中正常使用的关键反馈点。 Step 4: Execution of qualification protocols for Excel spreadsheet 步骤4：Excel电子表格确认方案的执行After the validation, the team will develop the installation, operational, and performance qualification protocols as detailed above, execute each testing step appropriately, and record the results. 验证后，团队将制定如上所述的安装、运行和性能确认方案，适当地执行每个测试步骤，并记录结果。 If the qualification protocol has not been followed correctly, raise a protocol deviation report. 如果未能正确遵循确认方案，则提出方案偏差报告。 Evaluate each deviation with in-depth root cause analysis. Identify and implement the corrective and preventive actions. 通过深入的根本原因分析来评估每个偏差。确定并实施纠正和预防措施。 If the protocol needs to be changed, update the protocol revision register. The revised protocol must be approved before execution. 如需修改方案，应更新方案修订登记簿，修改后的方案须经批准后方可执行。 Compare all results against the pre-determined acceptance criteria. If any tests fail, document the results on a protocol deviation report with all the evidence. 将所有结果与预先确定的可接受标准进行比较。如果任何测试失败，请将结果连同所有证据一起记录在方案偏差报告中。 Could you conduct an error analysis and make the necessary changes on the spreadsheet to resolve the failure? Typically, all tests must then be repeated. 您是否可以进行错误分析并在电子表格上做出必要的更改以解决故障？通常，必须重复所有测试。 If you find the error resulted from an incorrect formula, the spreadsheet should be used for error analysis to determine the cause of the error. 如果发现错误是由错误的公式引起的，则应使用电子表格进行错误分析以确定错误的原因。 For example, Excel has error messages for cells and auditing tools for determining precedents and dependent tracers. 例如，Excel 具有针对单元格的错误消息和用于确定先例和相关追踪器的审计工具。 Could you perform an impact assessment of the error? Then, please modify the template appropriately, receive approval, and repeat all tests. 您能否对错误的影响进行评估？然后，请适当修改模板，获得批准，并重复所有测试。 Step 5: Prepare final report on Excel spreadsheet validation 步骤 5：准备Excel电子表格验证的最终报告After the execution of qualification tests, prepare a final report on the Excel spreadsheet validation summarizing the testing results. Explain any deviations during the testing and provide rationales for resolving any deviations. 执行合格测试后，准备一份Excel电子表格验证的最终报告，总结测试结果。解释测试过程中出现的任何偏差，并提供解决任何偏差的理由。 Could you attach all the associated records and submit the final report for review and approval? 您能否附上所有相关记录并提交最终报告以供审核和批准？
Validated spreadsheet 经过验证的电子表格 How to manage validated Excel spreadsheets? 如何管理经过验证的Excel电子表格？You must take appropriate measures to prevent unwanted modifications to validated spreadsheets that may compromise the file’s validation status. 您必须采取适当的措施，防止对已验证的电子表格进行不必要的修改，因为这可能会损害文件的验证状态。 i. Prevent unauthorized access to the validated spreadsheet 防止未经授权访问已验证的电子表格You must protect the master copy of the validated unauthorized modification. For example, the spreadsheet shall be available to authorized users as “read-only.” 您必须保护已验证的未经授权修改的主副本。例如，电子表格应以“只读”方式供授权用户使用。 Authorized users will be given access after they have been trained on the use of the spreadsheet. 授权用户在接受电子表格使用培训后将被授予访问权限。 Where networks are employed for the spreadsheet, it will typically be stored in a network directory that allows authorized users to access it. 当使用网络存储电子表格时，它通常会被存储在允许授权用户访问的网络目录中。 In this instance, storing a copy of the spreadsheet application on the local computer’s hard drive must be prohibited. 在这种情况下，必须禁止在本地计算机的硬盘上存储电子表格应用程序的副本。 ii. Training of users 用户培训Please train your employees on the proper use of validated spreadsheets. The objective of the training should include: 请培训您的员工正确使用经过验证的电子表格。培训目标应包括： –How to use the spreadsheet application, including how to print the spreadsheet application report 如何使用电子表格应用程序，包括如何打印电子表格应用程序报告 –The procedure for storing spreadsheet application reports (if applicable) 存储电子表格应用报告的程序（如果适用） iii. Storage of completed electronic files 已完成电子文件的存储When you enter new data in the spreadsheet, it processes it according to the formula, and the calculated results become a new electronic file. 当你在电子表格中输入新的数据时，它会根据公式进行处理，计算结果变成一个新的电子文件。 The new electronic file should be stored under a new name in a designated area of the LAN server. 新的电子文件应以新名称存储在局域网服务器的指定区域。 Follow these rules when storing completed electronic files. 存储完成的电子文件时请遵循这些规则。 –Files should be named using a convention approved by the quality assurance. 文件应使用质量保证批准的惯例命名。 –The file name of the completed spreadsheet electronic report should be recorded in a notebook or other similar documentation system as a cross-reference. 已完成的电子表格电子报告的文件名应记录在笔记本或其他类似的文档系统中，作为交叉引用。 –During the review of notebook or other similar documentation system data, the reviewer should ensure that the electronic file has been stored correctly. 在审查笔记本或其他类似的文档系统数据时，审查人员应确保电子文件已正确存储。 Re-validation of Excel spreadsheet formulas 再验证Excel电子表格公式Review the spreadsheet at least once every three years to ensure the effectiveness of the validation parameters and the integrity of the formula. 每三年至少审查一次电子表格，以确保验证参数的有效性和公式的完整性。 Re-validation may also be triggered by installing an upgrade of the spreadsheet program (Change Control System) or by changes in the LAN (e.g., system crashes). 安装电子表格程序（变更控制系统）的升级或 LAN 的变更（例如，系统崩溃）也可能触发再验证。 If changes are required in a validated spreadsheet, it should be managed by a change committee in line with the change control procedures. 如果验证后的电子表格需要变更，则应由变更委员会按照变更控制程序进行管理。 Conclusion 结论For many of us, Excel spreadsheets are indispensable tools in the pharmaceutical industry. 对于我们许多人来说，Excel电子表格是制药行业不可或缺的工具。 Depending on the use and criticality, some complex Excel spreadsheets require rigorous validation to ensure their outcomes are accurate, reliable, and consistent. 根据用途和关键性，一些复杂的Excel电子表格需要严格验证以确保其结果准确、可靠和一致。 But what does this “validation” entail, and why is it so critical for professional applications? 但是这种“验证”包含什么？为什么它对于专业应用如此重要？ Validation of Excel spreadsheets ensures that they perform as intended, are free from errors, and comply with regulatory standards. Excel电子表格的验证可确保其按预期运行、没有错误并符合监管标准。 Whether the spreadsheet is used for laboratory data analysis, batch production records, or inventory management, validation is crucial to maintaining the integrity and accuracy of the information and outcomes it presents. 无论电子表格用于实验室数据分析、批量生产记录还是库存管理，验证对于维护其呈现的信息和结果的完整性和准确性都至关重要。 It is important to develop clear and meaningful functional requirements for a complex spreadsheet before it is handed down to the experts to develop the entire spreadsheet application. 在将复杂的电子表格交给专家开发整个电子表格应用程序之前，制定清晰且有意义的功能需求非常重要。 Once the spreadsheet is created using complex formulas, macros, lookup tables, or sophisticated functions and logic, it falls into the GAMP 5 category, which requires a full set of qualification tests. 一旦使用复杂公式、宏、查找表或复杂的函数和逻辑创建电子表格，它就会属于 GAMP 5 类别，需要进行一整套确认测试。 For instance, installation qualification (IQ) ensures that the spreadsheet has been designed, developed, supplied, and installed according to user requirements and functional specifications. 例如，安装确认 (IQ) 确保电子表格是根据用户要求和功能规范进行设计、开发、供应和安装的。 Operational qualification (OQ) tests the spreadsheet’s functionalities under defined conditions to verify that it operates as designed. 运行确认 (OQ) 在定义的条件下测试电子表格的功能，以验证其是否按设计运行。 The performance qualification (PQ) verifies that the spreadsheet consistently delivers accurate results in real-world scenarios, offering confidence in its day-to-day operations. 性能确认 (PQ) 验证了电子表格在现实场景中始终如一地提供准确的结果，从而为其日常运营提供了信心。 Once an Excel spreadsheet is validated, the users should be trained on its correct use. User access should be controlled, and the file should be stored securely to avoid accidental modifications. Excel电子表格通过验证后，应培训用户正确使用。应控制用户访问，并安全存储文件，避免意外修改。 A validated spreadsheet should be re-validated at least once every three years to check the effectiveness of validation parameters. 经过验证的电子表格应至少每三年再验证一次，以检查验证参数的有效性。 By understanding and applying this Excel spreadsheet validation approach we have established in this article, you can safeguard your work from potential pitfalls and errors, ensuring that decisions made using the spreadsheet are sound and reliable. 通过理解和应用我们在本文中建立的Excel电子表格验证方法，您可以保护您的工作免受潜在的陷阱和错误的影响，确保使用电子表格做出的决策是合理可靠的。 FAQ 常问问题1. What is Excel spreadsheet validation? 什么是Excel电子表格验证？ Excel spreadsheet validation involves developing and testing spreadsheets to ensure they process information accurately, completely, and reproducibly. This means confirming that the data and formulas are reliable and meet regulatory requirements in GMP environments. Excel电子表格验证涉及开发和测试电子表格，以确保它们准确、完整且可重复地处理信息。这意味着确认数据和公式可靠并符合 GMP 环境中的监管要求。 2. Why is validation of Excel spreadsheets required? 为什么需要验证Excel电子表格？ Validation is necessary to ensure that Excel spreadsheets used in GMP settings provide accurate, consistent, and complete information. This is crucial because spreadsheet errors could lead to incorrect decisions that adversely affect product quality and patient safety. 验证是确保 GMP 设置中使用的Excel电子表格提供准确、一致和完整的信息的必要条件。这一点至关重要，因为电子表格错误可能会导致错误决策，从而对产品质量和患者安全产生不利影响。 3. What are the regulatory requirements for Excel spreadsheet validation? Excel电子表格验证的监管要求是什么？ Regulatory requirements for spreadsheet validation are outlined by frameworks like Good Automated Manufacturing Practice (GAMP) by ISPE. Spreadsheets are categorized into different GAMP levels based on complexity, which dictates the extent of validation needed: ISPE 制定的良好自动化生产规范 (GAMP) 等框架概述了电子表格验证的监管要求。电子表格根据复杂程度分为不同的 GAMP 级别，这决定了所需的验证程度： i. GAMP 3: Spreadsheets used solely for producing paper documents. GAMP 3：仅用于产生纸质文档的电子表格。 ii. GAMP 4: Spreadsheets with templates that include process steps. GAMP 4：带有包含流程步骤的模板的电子表格。 iii. GAMP 5: Spreadsheets with complex features such as macros, lookup tables, and sophisticated logic. GAMP 5：具有宏、查找表和复杂逻辑等复杂功能的电子表格。 4. How do I plan for Excel spreadsheet validation? 如何规划Excel电子表格验证？ Planning involves defining functional requirements, developing the spreadsheet application, and preparing for qualification testing. Key validation steps include: 规划包括定义功能需求、开发电子表格应用程序以及准备确认测试。关键验证步骤包括： i. Developing functional requirements: Define the spreadsheet’s purpose, formulas, macros, data entry methods, and report generation needs. 开发功能需求：定义电子表格的用途、公式、宏、数据输入方法和报告生成需求。 ii. Developing the spreadsheet: Create the spreadsheet according to the functional requirements, including data entry methods, formulas, and macros. 开发电子表格：根据功能需求创建电子表格，包括数据输入方法、公式和宏。 iii. Qualification testing: Prepare and execute installation, operational, and performance qualification tests. 确认测试：准备并执行安装、运行和性能确认测试。 5. What qualification tests are involved in Excel spreadsheet validation? Excel电子表格验证涉及哪些确认测试？ Validation of Excel spreadsheet involves the following qualification testing: Excel电子表格的验证涉及以下确认测试： i. Installation Qualification (IQ): Verify that the spreadsheet is installed and configured as required. 安装确认 (IQ)：确证电子表格是否按要求安装和配置。 ii. Operational Qualification (OQ): Test the spreadsheet’s functionality under defined conditions. 运行确认 (OQ)：在定义的条件下测试电子表格的功能。 iii. Performance Qualification (PQ): Ensure the spreadsheet performs accurately with real-world data and under actual operating conditions. 性能确认 (PQ)：确保电子表格在实际数据和实际运行条件下准确执行。 6. What types of tests are performed during validation? 验证期间进行哪些类型的测试？ Tests include: 测试包括： –Calculation test: Verify the accuracy of formulas and functions. 计算测试：验证公式和函数的准确性。 –Logical values test: Check the correctness of logical functions. 逻辑值测试：检查逻辑函数的正确性。 –Range/precision test: Test how the spreadsheet handles extreme values. 范围/精度测试：测试电子表格如何处理极值。 –Challenge condition test: Assess how the spreadsheet manages boundary and extreme inputs. 挑战条件测试：评估电子表格如何管理边界和极端输入。 –Performance test: Evaluate the spreadsheet’s ability to handle large datasets and complex calculations. 性能测试：评估电子表格处理大型数据集和复杂计算的能力。 –Error handling and recovery test: Ensure the spreadsheet manages errors and can recover data. 错误处理和恢复测试：确保电子表格能够管理错误并恢复数据。 –Integration and interface test: Check data import and integration from external sources. 集成和接口测试：检查从外部源的数据导入和集成。 –Audit trail and version control test: Verify that changes are logged and previous versions can be retrieved. 审计追踪和版本控制测试：确证是否记录了更改并且可以检索以前的版本。 –Backup and restoration test: Test the effectiveness of backup and recovery procedures. 备份和恢复测试：测试备份和恢复程序的有效性。 7. How do I manage validated Excel spreadsheets?7. 如何管理已验证的Excel电子表格？ To manage validated spreadsheets: 要管理已验证的电子表格： i. Prevent unauthorized access: Protect the master copy and control user access. 防止未经授权的访问：保护主副本并控制用户访问。 ii. Training: Train users on proper use and handling of the spreadsheet. 培训：培训用户正确使用和处理电子表格。 iii. Storage: Save completed files under new names and follow naming conventions. 存储：以新名称保存完成的文件并遵循命名约定。 iv. Re-validation: Review the spreadsheet at least every three years or when significant changes occur. 再验证：至少每三年或发生重大变更时审查一次电子表格。 8. What should I do if validation tests reveal issues?8. 如果验证测试发现问题，我该怎么办？ If issues are found during validation testing, document them in a protocol deviation report. Perform a root cause analysis, implement corrective actions, and update the validation protocol. After making the necessary changes, re-test the spreadsheet to ensure all issues are resolved. 如果在验证测试期间发现问题，请将其记录在方案偏差报告中。执行根本原因分析，实施纠正措施，并更新验证方案。进行必要的更改后，重新测试电子表格以确保所有问题都得到解决。 9. How often should I re-validate my Excel spreadsheets? 我应该多久再验证一次我的Excel电子表格？ Re-validation should be performed at least once every three years or whenever there are significant changes to the spreadsheet, such as upgrades to the software or changes in the operating environment. 应至少每三年进行一次再验证，或者在电子表格发生重大变更（例如软件升级或运行环境发生变化）时进行再验证。 |
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