Simplifying Compliance in Life Sciences with Engineering Document Management

Featuring Synergis Software, Merck, and IPS

Regulatory compliance, data integrity, and system validation remain some of the most complex challenges facing life sciences organizations today. Engineering drawings, CAD files, and technical documentation are foundational to GMP operations—but when those documents are fragmented across shared drives, legacy systems, and local desktops, the risk of errors, audit findings, and safety incidents increases dramatically.

What is this Webinar About?

This on-demand webinar brings together Synergis Software, Merck, and IPS to explore how modern Engineering Document Management Systems (EDMS) simplify compliance while supporting validation, operational efficiency, and global collaboration. Viewers gain a real-world perspective on how a leading pharmaceutical manufacturer transformed document control using Synergis Adept, supported by validation experts at IPS.

Engineers viewing documents in pharmaceutical manufacturing facility

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What You'll Learn by Watching the Webinar

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
Lessons learned from Merck's real-world EDMS implementation
How validation partners like IPS streamline CSV and data integrity efforts
Why configurable, non-customized systems accelerate adoption and upgrades

Who Should Watch this Webinar

Watch this webinar if you are:

Engineering, Facilities, or Maintenance leaders
Quality, Compliance, or Validation professionals
Manufacturing and Operations teams
IT and Digital Transformation leaders
Project managers and capital project teams
Organizations replacing legacy or unstable CAD systems

If your organization needs to simplify compliance, improve document control, and establish a single source of truth for engineering information, this webinar provides real-world insights from Merck, Synergis, and IPS.

Quality professional analyzing engineering documentation in manufacturing facility

Why Life Sciences Requires a Different Approach to Engineering Document Management

In life sciences environments, engineering document management ensures that only approved, current, and traceable documents are used across manufacturing, maintenance, quality, and validation activities. It provides a single source of truth for engineering information while meeting regulatory requirements such as FDA 21 CFR Part 11, EMA Annex 11, and data integrity expectations.

A life sciences–ready engineering document management system (EDMS) typically includes:

Version control to prevent the use of outdated drawings
Audit trails and traceability showing who changed what and when
Electronic signatures and approval workflows for compliance

Secure access controls to protect intellectual property and patient safety
Support for complex CAD files and references used in regulated facilities
Validation readiness to support audits and inspections

This guide answers the most common questions engineering teams ask about EDMS, including what it is, how it differs from other systems, what ROI it delivers, and how to implement it successfully. By replacing disconnected systems and manual processes, an EDMS turns document chaos into controlled, efficient workflows.

Why Are General Document Systems or Shared Drives Not Sufficient?

Neither general document systems nor shared drives provide any means of an audit trail, CAD reference control, or validation support. Unlike general document repositories or shared drives, engineering document management in life sciences is designed to support validated operations, reduce compliance and safety risk, and ensure engineering documentation remains accurate and inspection-ready throughout the asset lifecycle.

digital documents in file folders

Compliance professional in pharmaceutical facility

What Are the Compliance Risks of Poor Document Control?

The session begins by outlining a common reality in regulated industries: engineering information is scattered, duplicated, and difficult to govern. Without structured version control, audit trails, or standardized workflows, organizations struggle to meet requirements such as FDA 21 CFR Part 11, EMA Annex 11, and data integrity expectations.

Manual approvals, inconsistent folder structures, and unmanaged CAD references create hidden compliance and safety risks—especially when outdated drawings are used in active facilities.

How Merck Simplified Validation and Reduced Risk

Merck shares its firsthand experience replacing a legacy, unstable CAD document system with Synergis Adept, a configurable, off-the-shelf EDMS designed for regulated environments. After a near-miss safety incident highlighted the dangers of outdated drawings, Merck secured funding to implement a validated system that could manage complex CAD files, enforce version control, and serve as a centralized source of truth.

In the webinar, Merck explains how Adept now supports global sites with controlled workflows, secure access, digital signatures, and full auditability—ensuring that engineering, maintenance, safety, and operations teams always work from approved, current documentation. The benefits of Adept include:

Reduced Audit Risk

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Simplified Computer Systems Validation (CSV)

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Avoidable Use of Outdated Drawings

Improved Global Collaboration

The Role of IPS in Validation and Compliance Assurance

IPS provides insight into the computer systems validation (CSV) and data integrity considerations that accompany EDMS deployments in life sciences. Drawing on deep familiarity with both regulatory expectations and the Adept platform, IPS explains how early involvement, right-sized validation strategies, and structured testing help organizations accelerate compliance while avoiding over-engineering.

The discussion highlights best practices for defining intended use, managing data migration, supporting audit readiness, and aligning technical configuration with regulatory requirements.

Watch the on-demand webinar to see how Synergis Adept, combined with expert validation support from IPS, helps life sciences organizations like Merck simplify compliance, strengthen data integrity, and confidently scale engineering document management across the enterprise.

Engineering Document Management (EDM) in life sciences is the controlled, validated process of managing engineering drawings, CAD files, and technical documentation used in GMP-regulated facilities. It ensures documents are version-correct, traceable, audit-ready, and compliant with regulations such as FDA 21 CFR Part 11 and EMA Annex 11.
EDM supports regulatory compliance by providing controlled access, electronic signatures, version control, secure audit trails, and validated workflows. These capabilities help organizations meet electronic records, electronic signature, and data integrity requirements.
Validation ensures that the EDM system performs as intended and meets regulatory requirements throughout its lifecycle. The webinar highlights how early involvement of validation experts and right-sized CSV strategies simplify compliance while avoiding over-engineering.
Yes. The webinar shows how centralized EDM enables secure, role-based access to engineering documentation across global sites, ensuring consistency, collaboration, and compliance regardless of location.