Simplifying Compliance in Life Sciences with Engineering Document Management
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Learning Level: Intermediate
Session Length: 1 hour
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.
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.
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.
Learning Objectives
This webinar is ideal for life sciences professionals responsible for compliance, engineering, validation, quality, and IT. Key takeaways include:
- How EDMS supports FDA and EMA compliance requirements
- Why centralized engineering information reduces operational and safety risk
- Why configurable, non-customized systems accelerate adoption and upgrades
Also learn lessons from Merck’s real-world EDMS implementation and how validation partners like IPS streamline CSV and data integrity efforts
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