ISPE 良好实践指南-数字验证Digital Validation-2025（中英文）.pdfVIP

ISPE-DigitalValidation-2025

数字验证

@Clear1/103

ISPE-DigitalValidation-2025

Preface前言

TheadoptionofDigitalValidationTools(DVTs)inthelifesciencesindustryhighlightsanincreasing

commitmenttodataintegrity,operationalefficiency,andregulatorycompliance.However,transitioning

fromtraditional,paper-basedvalidationtoadigitallyintegratedframeworkremainsacomplexchallenge.

Organizationsoftenfaceobstacleswithimplementation,governance,systemintegration,andregulatory

adherence.Theevolvinglandscapeofglobalregulations,thevarietyofavailabletechnologies,andthe

heightenedauditorexpectationsfurthercomplicatethistransition,makingstructuredguidanceand

industry-widecollaborationessential.

生命科学行业采用数字验证工具（DVT），凸显了对数据完整性、运营效率和法规遵从性的日益承诺。然

而，从传统的基于纸面的验证过渡到数字集成框架仍然是一个复杂的挑战。组织在实施、治理、系统集

成和遵守监管方面经常面临障碍。全球监管格局的演变、可用技术的多样性以及审计师期望的提高使这

一转变更加复杂，因此结构化指导和全行业合作至关重要。

ThisGoodPracticeGuide(GPG)offerspractical,risk-basedbestpracticesfordefining,implementing,

andmanagingDVTswithinaregulatedenvironment.Developedbyaglobalteamofexpertsinvalidation,

regulatorycompliance,qualityassurance,anddigitaltransformation,thisGuidepresentsreal-world

insights,casestudies,andstructuredmethodologiestofacilitatethesuccessfulintegrationofdigital

validationintobusinessoperations.Itexploresregulatoryconsiderations,systemselection,data

managementstrategies,andcomplianceframeworks,equippingorganizationswiththenecessarytools

toenhancevalidationefficiencywhilemaintainingregulatoryrigor.

本良好实践指南（GPG）提供了在受监管环境中定义、实施和管理DVT的实用、基于风险的最佳实践。

本指南由验证、监管合规性、质量保证和数字化转型方面的全球专家团队开发，介绍了现实世界的见解、

案例研究和结构化方法，以促进数字验证成功融入业务运营。它探讨了监管考虑因素、系统选择、数据

管理战略和合规框架，为组织提供必要的工具，以提高验证效率，同时保持监管的