RX360，有出口需求的老师，应该对这个组织不陌生，它是一个审计联盟，也接受委托审计，认可度也比较高，所以大家经常会从它那边买审计报告。

今天要说的是其数据完整性模块在前几天发布的电子表格验证指南。数据完整性搞了这么多年，从GAMP5到OMCL电子表格验证，再到ECA数据治理中的电子表格章节，电子表格验证不是已经被验证出花了么，行业内不是要kill spreadsheet么？6202年不是得全面电子化了么？

但实际上，电子表格，仍旧在特定场合有它的投入产出比，有它的地位。老的指南也不一定跟上新的变化，比如OMCL指南时代，它也不可能会知道后面excel会变成O365的云产品，ECA也没考虑到后面O365的审计追踪功能bug因为上云后变成可能解决……

覆盖"评估→验证→运维→退役"全链，x-360 明确高/中/低三级风险（高风险=放行决策/规格评估；中=维护管理/仪器校准；低=备件跟踪），并要求"风险确定后记入验证计划、交付物随风险等级伸缩"。交付物清单化、可勾选执行
验证阶段 9 项交付物（Design & Purpose→业务需求→规划→配置→安全/访问配置→测试(IQ/OQ/PQ)→放行）+ 运维阶段 8 组控制（安全访问、计算保护、数据录入、版本控制、变更管理、备份恢复、定期审核、退役归档），每项下再细分可执行控制点。明确测试可采用 IQ（配置/版本/位置/访问验证）、OQ（公式计算准确性、边界、错误管理）、PQ（真实业务场景）三阶段。Rx-360（2026-09）引用了最新监管动态；ECA v3.0 的技术讨论停在 Excel 2013/2016 的技术局限（Track Changes 不适合作审计追踪、数字签名可移除等），未覆盖 Excel 365/新版本能力。

Rx-360 数据完整性指南——电子表格验证

Rx-360 Data Integrity Guide – Spreadsheet Validation

> 由 Rx-360 数据完整性工作组编制 · 发布于 2026 年 9 月

> Developed by the Rx-360 Data Integrity Working Group · Published September 2026

Rx-360 is a global nonprofit pharmaceutical supply chain membership consortium, offering the Joint Audit Program® suite of supplier qualification services. The Rx-360 mission is to protect patient safety by securing the global pharmaceutical supply chain. The consortium generates tools and guidance in service to the industry. Learn more at Rx-360.org.

Rx-360 是一个全球性非营利制药供应链成员联盟，提供联合审计计划®（Joint Audit Program®）系列供应商资质认定服务。Rx-360 的使命是保障全球制药供应链安全，从而保护患者安全。该联盟为行业编制工具与指南。了解更多请访问 Rx-360.org。

> 中英双语对照翻译 | 英文原文 + 简体中文译文

引言 · Introduction

Spreadsheets are widely used throughout regulated industries to support data management, calculations, reporting, decision-making, and quality system activities. When spreadsheets are used to support regulated processes, it is important to determine whether validation is necessary and to implement controls appropriate to their intended use and risk. This guide provides a risk-based framework for evaluating, validating, operating, and maintaining spreadsheets, drawing upon applicable regulatory expectations, industry guidance, and common inspection observations. The concepts and best practices presented are intended to support organizational decision-making and may be adapted to individual company procedures, risk tolerance, and compliance requirements.

电子表格广泛应用于受监管行业，用于支持数据管理、计算、报告、决策和质量体系活动。当电子表格用于支持受监管流程时，确定是否有必要进行验证，并实施与其预期用途和风险相适应的控制措施至关重要。本指南提供了一个基于风险的框架，用于评估、验证、操作和维护电子表格，借鉴了适用的法规要求、行业指南和常见检查观察项。所介绍的概念和最佳实践旨在支持组织决策，可根据各公司的程序、风险承受能力和合规要求进行调整。

目的 · Purpose

指南的使用 · Use of the Guide

This guide is based upon a foundation of regulations and guidance of documents related to the validation and management of spreadsheets. Content from publicly available sources (e.g., FDA, MHRA, etc.) will be provided within this guide. References to content requiring a subscription (e.g., ISPE, USP, Ph. Eur., etc.) will be provided.

本指南基于与电子表格验证和管理相关的法规及指南文件基础。指南中将提供来自公开来源（如 FDA、MHRA 等）的内容，同时提供需要订阅的内容（如 ISPE、USP、Ph. Eur. 等）的参考文献。

A summary of FDA 483 Observations with content around the spreadsheet validation will be provided to point to specific use cases, deficiencies, mitigation actions, and best practice recommendations to address various scenarios.

将提供与电子表格验证相关的 FDA 483 观察项（483 缺陷）摘要，以指明具体使用场景、缺陷、缓解措施和最佳实践建议，用于应对各种情形。

This guide is intended to provide general considerations for the validation, use, and maintenance of spreadsheets. The guide is not intended to be a specific ‘how-to’ model with precise details and exact requirements. The specific approach to spreadsheet validation may vary from one company to another and based on specific use case criticality (e.g., terminology, deliverables, roles & responsibilities, etc.), while still achieving the state of control required by the applicable regulations.

本指南旨在为电子表格的验证、使用和维护提供一般性考虑。本指南无意成为包含精确细节和确切要求的特定“操作手册”式范本。各公司可根据具体使用场景的关键性（如术语、交付物、角色与职责等）采用不同的电子表格验证方法，同时仍须达到适用法规所要求的受控状态。

The principles, quality concepts, and best practices outlined here may be considered a generally accepted approach, based upon the experience and perspectives of the authors (i.e., SMEs in this area). This guide is to be used only to provide context to evaluations and/or discussions by users of this guide and their organization(s). This guide is not officially endorsed by any government agency, trade association, or private company. The guide should not be viewed as a validation or endorsement of any product or organization by Rx- 360. Additionally, it is not intended to be construed as regulation, directive, or legal / regulatory advice.

本文所述原则、质量理念和最佳实践可视为一种公认的方法，基于作者（即该领域的主题专家）的经验和观点。本指南仅用于为本指南使用者及其所在组织提供评估和/或讨论的背景。本指南未经任何政府机构、行业协会或私营公司官方认可。本指南不应被视为 Rx-360 对任何产品或组织的验证或认可。此外，本指南无意被解释为法规、指令或法律/监管建议。

范围 · Scope

This guide categorizes risks into three levels: High, Medium, and Low. These risk levels are based on the intended use of the spreadsheet, data it contains, and the corresponding potential risk to product quality, patient safety, and/or regulatory compliance. The descriptions and examples below provide guidance regarding determination of the appropriate risk level, potential deliverables, and controls.

本指南将风险分为三个等级：高风险、中风险和低风险。这些风险等级基于电子表格的预期用途、所含数据，以及对产品质量、患者安全和/或法规符合性构成的相应潜在风险。下文中的描述和示例为确定适当的风险等级、潜在交付物和控制措施提供指导。

This guide separates spreadsheet validation into two phases, Validation Phase and Operation and Maintenance Phase.

本指南将电子表格验证分为两个阶段：验证阶段和操作、使用和维护阶段。

电子表格验证 · Spreadsheet Validation

风险等级评估 · Risk Level Assessment

The Risk Level Assessment is used to determine the validation of deliverable(s), requirements, and level of control necessary for the spreadsheet based on the assigned risk. Considerations for the risk originate from the intended use of the spreadsheet and the data it contains. Once the risk is determined, document assessment/rationale in the Validation Plan.

风险等级评估用于根据所分配的风险，确定电子表格所需的交付物验证、需求和控制水平。风险的考量源于电子表格的预期用途及其所含数据。风险确定后，应在验证计划中记录评估/依据。

Below are examples of risk considerations to determine the risk level.

以下为确定风险等级的风险考量示例。

High Risk: Spreadsheets where the data directly impacts regulatory compliance, quality of products, or patient safety. This includes examples such as evaluating data against specification limits and considering calculations for product release decisions.

高风险：数据直接影响法规符合性、产品质量或患者安全的电子表格，包括如对照质量标准限度评估数据、为产品放行决策进行计算等情形。

Medium Risk: Spreadsheets where the data indirectly impacts processes that support regulatory compliance, quality of products, or safety of patients. This includes examples such as maintenance management activities (e.g., tracking and scheduling preventive and corrective maintenance) and calibrations of instruments/equipment.

中风险：电子表格中的数据间接影响支持法规符合性、产品质量或患者安全的过程。示例包括维护管理活动（如预防性/纠正性维护的跟踪台账）以及仪器/设备的校准记录。

Low Risk: Spreadsheets where the data has no impact on regulatory compliance, quality of products or safety of patients. This includes examples such as tracking parts and consumables.

低风险：电子表格中的数据对法规符合性、产品质量或患者安全没有影响。示例包括部件和消耗品的台账。

验证阶段 · Validation Phase

Listed below are the validation phase deliverables in a typical sequential order. The level of details in the validation documents should reflect the risk, complexity, and use of the data output from the spreadsheet.

以下按典型的先后顺序列出验证阶段的交付物。验证文件的详细程度应反映电子表格输出数据的风险、复杂性和用途。

The Validation Phase consist of the following main deliverables.

验证阶段包括以下主要交付物。

·Design and Purpose: A statement to define the purpose and intended use of the spreadsheet. The design and purpose feed into defining requirements

·设计与目的：界定电子表格目的和预期用途的说明。设计与目的用于确定需求。

nIntended Use of the spreadsheet:

n电子表格的预期用途：

o Clear structure (inputs, calculation, outputs, etc.,)

清晰的结构（输入、计算、输出等）

o Calculate results (e.g., %RSD, Infusion Rate, Stability, etc.,)

计算结果（如 %RSD、输注速率、稳定性等）

o Define what cells require second person verification,

确定哪些单元格需要第二人复核，

nResult transfer (e.g., LIMS)

n结果传输（如 LIMS）

·Business Requirements: Should reflect the business's use/process, design, and purpose. Requirements should be written to ensure that they are testable or objectively verifiable.

·业务需求：应反映业务的使用/流程、设计和目的。需求的编写应确保其可测试或可客观验证。

·Planning: The planning phase is often documented in a Validation Plan. The Validation Plan typically defines purpose and scope, overview, roles and responsibilities, deliverables, testing approach, acceptance criteria, and approval requirements.

·规划：规划阶段通常在验证计划中记录。验证计划通常定义目的与范围、概述、角色与职责、交付物、测试方法、验收标准和批准要求。

nDefine the spreadsheet validation deliverables/process:

n定义电子表格验证交付物/流程：

o What validation activities are required

需要哪些验证活动

o Who and how will they be performed

由谁执行以及如何执行

o Define validation outputs

定义验证输出

o Define how you accept the spreadsheet for use

定义如何验收电子表格并投入使用

·Configuration: Spreadsheets should be configured based on approved requirements. Calculations, formulas, macros, and logic should be implemented as defined. Cells containing formulas should be protected using security controls from unauthorized modification or deletion. A clear separation of inputs, calculations, and outputs helps reduce the risk of user errors.

·配置：电子表格应基于已批准的需求进行配置。计算、公式、宏和逻辑应按定义实施。包含公式的单元格应通过安全控制加以保护，防止未经授权的修改或删除。输入、计算和输出的清晰分离有助于降低用户出错的风险。

nSecurity & Access Control Configuration: Role based access controls should be implemented to restrict viewing, data entry, modification, and approval activities. Unauthorized access, modification, or deletion of spreadsheet content should be prevented. Security controls may include locked cells, password protection, restricted folders, and controlled download permissions based on risk.

n安全性（安全）与访问控制配置：应实施基于角色的访问控制，以限制查看、数据录入、修改和批准活动。应防止对电子表格内容进行未经授权的访问、修改或删除。安全控制措施可包括锁定单元格、密码保护、受限文件夹以及基于风险的受控下载权限。

nConsiderations for access control

n访问控制的考量

• Spreadsheet stored in a secured location

电子表格存储在安全位置

• Number of User Profiles (admin, power user, user) and responsibilities

用户配置（管理员、超级用户、普通用户）的数量及职责

• Number of users

用户数量

• Creation of audit trails

审计追踪的建立

·Testing: Once configuration is complete, execute testing to demonstrate it performs as intended. Testing should include, as applicable, calculation accuracy, boundary conditions, input/output verification, and security controls. Testing could be performed using the IQ, OQ, and PQ format.

·测试：配置完成后，执行测试以证明其按预期运行。测试应在适用时包括计算准确性、边界条件、输入/输出验证和安全控制。测试可采用 IQ、OQ 和 PQ 的形式进行。

·Installation Qualification: Configuration verification insuring correct version, controlled location, and access controls

·安装确认（IQ）：配置验证，确保版本正确、存放位置受控且访问控制到位。

·Operational Qualification: Accuracy of formulas and calculations, boundary testing and error management

·运行确认（OQ）：公式和计算的准确性、边界条件测试及错误管理

·Performance Qualification: Tested in a real-world scenario to represent business use

·性能确认（PQ）：在真实场景中进行测试，以代表业务使用情况。

·Test results should be documented and reviewed.

·测试结果应予以记录并审核。

·Release: Validated spreadsheets should be reviewed and approved by designated personnel prior to operational use. Approval should indicate that validation activities are complete, and acceptance criteria have been met, and the spreadsheet is approved for use.

·放行（发布）：经验证的电子表格在投入运行使用前，应由指定人员审核和批准。批准应表明验证活动已完成、验收标准已满足，且该电子表格已获准使用。

操作、使用和维护阶段 · Operation, Use, and Maintenance Phase

Operation and use of validated spreadsheets should be controlled to prevent the overwriting of data, unauthorized copying, or unintended modification. Data entry should be limited to configured fields. Controls such as templates, file-naming conventions, and second-person verification can help maintain data integrity during routine use.

经验证的电子表格的操作和使用应受控，以防止数据被覆盖、未经授权的复制或意外修改。数据录入应仅限于配置的字段。模板、文件命名规范和第二人复核等控制措施有助于在日常使用中保持数据完整性。

The Operation and Maintenance Phase consists of the following deliverables.

操作、使用和维护阶段包括以下交付物。

·Security controls and Access Management: Controls to ensure only authorized individuals can access the spreadsheet.

·安全控制措施与访问管理：确保只有经授权的人员才能访问电子表格的控制措施。

nRole-based access (e.g., admin, power user, user)

n基于角色的访问（如管理员、高级用户、普通用户）

nRestricted access to open or use the spreadsheet

n限制打开或使用电子表格的权限

nSeparation of privileges for creation, modification, review, and approval

n创建、修改、审核和批准的权限分离

nAccess granted and removed through a controlled and documented process

n通过受控且有记录的过程授予和撤销访问权限

nPeriodic review of user access

n用户访问权限的定期审核

·Protection of Calculations: Controls to prevent unauthorized or accidental modification of critical content.

·计算保护：防止关键内容被未经授权或意外修改的控制措施。

nLocked cells for formulas, macros, and logic

n对公式、宏和逻辑锁定单元格

nProtection of hidden sheets and named ranges

n隐藏工作表与命名区域的保护

nPassword protection for structural changes

n对结构性变更设置密码保护

nPrevention of insertion, deletion, or modification of formula cells

n防止插入、删除或修改公式单元格

nClear separation of input, calculation, and output areas

n明确区分输入、计算和输出区域

·Data Entry Controls: Controls to ensure users can only enter valid and expected data.

·数据录入控制：确保用户只能录入有效且预期数据的控制措施。

nRestricted data entry to designated input fields

n数据录入仅限于指定的输入字段

nUse of data validation rules (e.g., drop-downs, limits, formats)

n使用数据验证规则（如下拉列表、限制、格式）

nPrevent the overwriting populated data

n防止覆盖已录入数据

nControls to prevent deletion or alteration of entered data without detection

n防止已录入数据在未被察觉的情况下被删除或更改的控制措施

nSecond-person verification for critical data entry where required

n在需要时对关键数据录入进行第二人复核

·Version Control: Controls to ensure only the correct, approved version is used.

·版本控制：确保仅使用正确且经批准的版本的控制措施。

nMaster template/copy should be stored in a secured, restricted location

n主模板/副本应存放在安全、受限的位置

nUnique version identification within the spreadsheet

n电子表格内的唯一版本标识

nClear identification of approved status

n明确标识批准状态

nControlled storage location for approved versions

n经批准版本的受控存储位置

nPrevention of use of obsolete or superseded versions

n防止使用过期或已取代的版本

nRemoval or securing of prior versions to prevent unintended use

n移除或封存旧版本，以防止意外使用

·• Change Management: Controls in place to ensure changes are detectable and attributable.

·变更管理：建立相应控制措施，确保变更可被检测并可追溯归因。

nDocumented revision change history

n记录修订变更历史

nDocumented change author, reviewer, and approver

n记录变更的编制人、审核人和批准人

nChange monitoring process to identify unauthorized changes

n变更监控流程，以识别未经授权的变更

·•Backup and Recovery: Controls in place to ensure data availability and data integrity

·备份与恢复：建立控制措施以确保数据可用性和数据完整性。

nPerform routine backup of spreadsheet

n对电子表格进行日常备份

nProtection of backup from unauthorized changes or modifications

n保护备份免受未经授权的更改或修改

nVerification of backup and recovery

n备份与恢复的确认

nDefined record retention based on approved policy

n基于经批准的政策明确定义记录保留要求

· Periodic Review: Spreadsheets should be evaluated to ensure the spreadsheet is operating as configured and in a validated manner. This will vary based on the Risk Level. The evaluation may include the following reviews:

·定期审核（周期性审查）：应对电子表格进行评估，以确保其按配置且以经过验证的状态运行。评估方式将随风险等级的不同而不同。评估可包括以下审核内容：

nSpreadsheet monitoring for access and usage

n对电子表格的访问和使用情况进行监控

nAppropriate security and user access

n适当的安全性与用户访问

nReview for changes to the spreadsheet

n对电子表格变更的审核

nIssues, problems, deviations

n问题、故障、偏差

·• Retirement and Archival: Controls to prevent use after end of lifecycle

·退役与归档：采取措施防止生命周期结束后继续使用

nDocumented formal retirement of spreadsheet

n电子表格的正式退役记录在案

nRemoval of active or shared spreadsheet to prevent accidental use

n移除在用或共享的电子表格，以防止意外使用

nArchival of spreadsheet in non-editable format

n以不可编辑格式归档电子表格

nRetention of historical data for inspection and/or reconstruction

n保留历史数据，用于检查和/或重建

附录——法规引用对照表 · Appendix – Regulations Reference Guidance Sheet

免责声明 · Disclaimer

DISCLAIMER: This document is for informational purposes only. Users are responsible for ensuring that the document meets their individual needs and adjusting it accordingly. RX-360 MAKES NO WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, AS TO THE INFORMATION IN THIS DOCUMENT. Complying with all applicable laws is the responsibility of the user.

免责声明：本文档仅供参考。使用者有责任确保本文档满足其自身需求并据此进行调整。RX-360 对本文档中的信息不作任何明示、默示或法定形式的保证。遵守所有适用法律是使用者的责任。