Storytelling in Project Management for Validating FDA-Regulated Computer Systems: How to Captivate & Inspire the Team

Overview:

Validating FDA-regulated (“GxP”) computer systems often stalls for reasons that have nothing to do with whether a team knows compliance—and everything to do with whether the work is understood, supported, and defensible across functions. Validation is inherently cross-functional (IT, QA, manufacturing, lab, regulatory). When projects are communicated in technical jargon or “QA-only” language, non-technical stakeholders disengage, approvals slow down, and teams lose momentum.

At the same time, organizations get stuck because FDA tells you what is required but does not prescribe how to do it—there is no single “FDA-approved” validation method. This creates real operational confusion: vendors can’t legitimately claim a system is “FDA-compliant,” “validated,” or “Part 11 compliant,” and the client organization still must build—and be able to defend—the validation approach. Add to that the reality that 21 CFR Part 11 was intentionally designed to allow flexibility, which often leads to high interpretation and inconsistency in how controls are implemented and justified.

Where this becomes most painful is during audits and inspections. Inspectors expect alignment between documentation and real-world understanding of how the system is used. If project teams can’t clearly explain the rationale behind requirements, risks, testing decisions, and ongoing controls, inspection stress goes up—and defensibility goes down.

This webinar shows how to use storytelling as a practical project-management tool (not “fluff”) to keep validation moving and make it easier to defend. You’ll learn how to build a clear narrative that connects the system’s purpose to risk, compliance controls, and day-to-day use—so teams align faster, documentation reads more logically, and stakeholders understand the “why,” not just the “how.” The session ties storytelling directly to core PM building blocks—charter, planning, risk assessment, roles/responsibilities, training and change management, communication, and lifecycle maintenance—so your validation story holds up from “cradle to grave.”

Areas covered in the session:

• How storytelling improves alignment, approvals, and audit/inspection confidence in GxP validation projects.
• What FDA expects from computer system validation and why defensibility still sits with your organization.
• The GxP validation lifecycle across the SDLC: plan, build/configure, test/validate, operate/maintain, and retire.
• The PM fundamentals that keep validation moving: charter, detailed plan, roles/responsibilities, risk planning, and communication.
• Risk-based validation best practices: clear requirements, traceability, fit-for-purpose testing depth, and documented justification.
• Operational controls that protect the validated state: access/roles, audit trails, incidents, backups, and recovery.
• A simple storytelling framework (characters, conflict, resolution) tailored for QA, IT, business owners, and executives.
• Applying storytelling to validation deliverables (URS, risk, test plans, deviations, RTM) so reviews move faster and documents read logically.
• Part 11 and data integrity anchors (including key SOP expectations and ALCOA+ mindset) to keep the narrative compliance-ready.
• Common pitfalls to avoid and a practical way to implement these techniques in your next validation project.

Why should you attend?

Validation projects don’t fail only because of technical gaps—they fail when cross-functional teams lose clarity, alignment, and momentum. This session shows how to use a simple storytelling approach to keep stakeholders engaged, speed up reviews/approvals, and reduce friction across QA, IT, and business teams while still staying grounded in defensible validation logic.

You’ll learn how to turn validation work into a clear, audit-ready narrative that connects system purpose to requirements, risks, testing decisions, and ongoing controls—so your documents read more logically, your rationale is easier to explain, and inspection conversations are less stressful.

You’ll also walk away with practical techniques you can apply immediately—whether you’re kicking off a new implementation, rescuing a stalled validation effort, or trying to maintain the validated state over time (change control, access, audit trails, incidents, backups, recovery, and more).

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to aid your teams in post-session implementation.

Who will benefit?

This session is designed for professionals who lead, support, review, or defend validation activities for FDA-regulated computer systems and need stronger cross-functional alignment, clearer rationale, and smoother inspection-ready communication—those include:

• Computer System Validation (CSV) Manager / Lead
• CSV Project Manager
• GxP Program Manager (Digital / Systems)
• Validation Project Manager (Quality / IT)
• Quality Assurance (QA) Manager / QA Lead (Systems / Validation)
• Quality Systems Manager
• IT Quality / IT Compliance Manager
• Computer Systems Quality Assurance (CSQA) Specialist
• Validation Engineer (Computer Systems / Automation / IT)
• Digital Quality / Digital Compliance Lead
• SDLC / Systems Implementation Project Manager (GxP environments)
• Business System Owner (LIMS / MES / eQMS / ERP / EDMS)
• Application Owner / Product Owner (GxP systems)
• QA Reviewer / Approver for Validation Deliverables
• Risk Management Lead (GxP systems)
• Data Integrity Lead / Manager
• 21 CFR Part 11 Compliance Lead
• Quality Compliance / Audit Readiness Manager
• Internal Auditor (GxP / Quality Systems / Computerized Systems)
• Regulatory Compliance Manager (GxP systems oversight)
• Change Control / Configuration Management Lead (GxP systems)
• Training & Organizational Change Management Lead (GxP implementations)
• IT Project Lead / Technical Lead supporting validated systems
• Supplier / Vendor Quality Manager (software/service providers)