ServiceNow Isn’t GxP — Until You and Mindful FDA Make It GxP

Too many teams in regulated pharma and biotech still say:
“ServiceNow is GxP.”

It’s not.

ServiceNow is GxP-capable, not GxP-compliant out of the box. That distinction matters — especially once you start using it for change control, deviations, CAPAs, complaints, or any workflow that can impact product quality, patient safety, or data integrity.

The moment you do that, regulators stop caring that it’s “just ITSM.”
They care that it’s now supporting GxP processes.

CAPABILITY ≠ COMPLIANCE

Out of the box, ServiceNow gives you:
• Flexible workflows
• Rapid configuration
• Frequent platform updates
• Strong audit and security features

What it does not give you is:
• Your intended use
• Your risk assessment
• Your validation rationale
• Your release controls

Those are your responsibility.

CSA (Computer Software Assurance) didn’t change that — it clarified how to do it smarter.

CSA CHANGES HOW YOU VALIDATE — NOT WHETHER YOU VALIDATE

CSA doesn’t mean “less rigor.”
It means right-sized rigor.

If ServiceNow is configured to support GxP processes, regulators expect:
• Clear intended use tied to patient safety, product quality, and data integrity
• Risk-based assessment of configurations and integrations
• Validation activities focused on what could actually go wrong
• Evidence that changes are controlled, reviewed, and verified
• Ongoing assurance that production still matches what you validated

What CSA does not expect:
• Scripted test cases for every form field
• Copy-paste IQ/OQ/PQ templates
• Treating low-risk workflow tweaks like custom code

That’s where agile thinking matters.

AGILE SERVICENOW WITHOUT VALIDATION DRIFT

ServiceNow is inherently agile:
• Continuous releases
• Configuration over code
• Rapid iteration
• Frequent vendor updates

Trying to validate it like a static, waterfall system is how teams get into trouble.

Not because agile is risky —
but because uncontrolled change is.

Validation drift happens when:
• PROD changes faster than documentation
• Configuration updates aren’t assessed for GxP impact
• Platform upgrades aren’t evaluated against intended use
• Teams assume “vendor-managed” means “vendor-validated”

CSA and GAMP 5 Second Edition both push the same solution:
focus on risk, controls, and outcomes — not artifacts.

THE BOTTOM LINE FOR 2026

If you’re using ServiceNow for GxP processes and haven’t defined:
• What it’s intended to do
• What risks actually matter
• How changes are evaluated and released
• How you know it’s still in a validated state

Then you don’t have a GxP ServiceNow instance.

You have an unvalidated platform supporting regulated workflows — and that’s exactly how data integrity gaps and audit findings happen.

ServiceNow can be an excellent choice for regulated quality and IT processes.

It just isn’t GxP
until you make it GxP — using agile principles, CSA thinking, and validation that actually reflects how the platform works.