Simplifying Compliance in Life Sciences with Engineering Document Management

Sponsored
Learning Level: Intermediate
Time: 1300 - 1400 ET 
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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Speakers

Livia Wiley
Industry Leader
Synergis Software
Craig Schuler
Solutions Architect
Synergis Software
John Niziolek
Director Digital Transformation Technology Services & Medical Gases
IPS - Integrated Project Services, LLC.