ISPE Webinar丨以工程文档管理简化生命科学合规工作

学习水平：中级

北京时间：2026年07月10日（周五）

时间：12:00-13:00

Regulatory compliance, data integrity, and system validation remain complex challenges in life sciences—especially when engineering drawings, CAD files, and technical documents are fragmented across systems. In GMP-regulated environments, poor control of this information increases the risk of audit findings, operational errors, and safety incidents.

法规合规、数据完整性与系统验证始终是生命科学领域的复杂难题 —— 当工程图纸、CAD 文件及技术文档分散存储于多个系统时，这一问题尤为突出。在受 GMP 规范约束的生产环境中，若对此类资料管控不善，将提升核查缺陷、操作失误与安全事故的发生风险。

This webinar features Synergis Software, Merck, and IPS, exploring how Engineering Document Management Systems (EDMS) simplify compliance while supporting validation and global collaboration. Through a real-world case study, Merck shares how it replaced a legacy CAD document system with a validated EDMS to improve document control, reduce risk, and streamline validation.

本次网络研讨会由协同软件（Synergis Software）、默克（Merck）及 IPS 公司联合主讲，探讨工程文档管理系统（EDMS）如何在支撑验证工作与全球协同办公的同时简化合规流程。默克将结合真实落地案例，分享企业如何淘汰老旧 CAD 文档系统，上线一套经过验证的工程文档管理系统，以此强化文档管控、降低合规风险并简化验证流程。

Attendees will also gain insight from IPS on right-sized, risk-based validation strategies and data integrity best practices. Participants will leave with practical approaches to ensure engineering information is accurate, controlled, and audit-ready across the asset lifecycle.

参会者还将听取 IPS 分享适配企业规模、基于风险的验证策略以及数据完整性最佳实践。参会人员会后可掌握实操方案，确保设备全生命周期内的工程资料准确规范、管控到位，随时可迎接审计核查。

This webinar is ideal for life sciences professionals responsible for compliance, engineering, validation, quality, and IT. Key takeaways include:

本次线上研讨会适合负责合规、工程、验证、质量及信息技术板块的生命科学行业专业人士参与。核心收获要点如下：

Also learn lessons from Merck’s real-world EDMS implementation and how validation partners like IPS streamline CSV and data integrity efforts

同时了解默克落地工程文档管理系统（EDMS）的真实实践经验，以及 IPS 这类验证服务商如何简化计算机化系统验证（CSV）与数据完整性相关工作。

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