Validated state
ProcessX arrives validated, and each ProcessX release is validated. The recurring work that keeps internal and third-party GxP systems validated (deciding scope, periodic and audit trail review, low-risk change) runs as governed workflow instead of documents and spreadsheets.
Part 11 e-signature on the test summary
Inspection only. The example record and its signature state stay unchanged.What ships in validated state
Applicability assessment, periodic and audit trail review, GxP standard change, and an app validated on every release.
Regulatory applicability assessment
A documented, approved decision on whether each internal or third-party system is GxP, with risk scope recorded once across quality, security and data — including whether AI capabilities must be assessed before they touch a regulated process.
Periodic and audit trail review
Reviews scheduled, assigned and evidenced for every GxP system — on a fixed cadence or triggered when risk or scope changes — with overdue work visible, and audit trail reviews with outcomes you can report instead of reconstruct.
GxP standard change
Pre-approved, controlled standard changes for low-risk work on validated systems, so routine changes stop waiting on the full change process.
Validated on every release
Each ProcessX release is validated, so you verify your own intended use and configuration instead of validating a custom build. As an optional USDM service, when you upgrade ServiceNow, USDM runs the automated regression package on your validation instance and hands your Quality the results to review and sign before you move to production.
How validated state holds release after release.
Watch how regulatory applicability, periodic and audit trail reviews, GxP standard changes, and platform upgrade regression run on ServiceNow — so validation stays current as living records instead of static binders.
The controls that apply, and the evidence they leave
The controls live inside the ServiceNow records, not in separate documents, and everything the workflow does leaves evidence.
Controls enforced
- C1Part 11 and Annex 11 electronic signatures on assessments and review outcomes
- C2Review schedules, gate owners and role segregation enforced by the workflow
- C3Standard changes limited to pre-approved, controlled templates
- C4Immutable audit trail on every assessment, review and decision
Evidence produced
- E1A documented, approved GxP determination for every internal and third-party system
- E2Periodic and audit trail review outcomes on the system record
- E3Validation evidence for each ProcessX release
- E4Regression results from each upgrade, reviewed and signed by your Quality
What FDA CSA, EU Annex 11, and Part 11 expect across a system’s life
Validation is not a one-time go-live binder. Regulators expect documented GxP applicability for every system, risk-scaled assurance focused on intended use, scheduled periodic and audit trail reviews with recorded outcomes, and controlled regression whenever underlying SaaS platforms upgrade.
- FDA CSA (2022)ProcessX arrives validated on every release so assurance focuses on your configured intended use and high-risk workflows rather than repeating baseline script bindersRisk-scaled
- ANNEX 11 §4 & §11System inventory scope, GxP applicability determinations, and scheduled or event-triggered periodic evaluations run as assigned, signed ServiceNow workflowsScheduled & signed
- ANNEX 11 §9Audit trail reviews execute as recurring records with documented scope, exceptions, and reviewer sign-off rather than ad-hoc pre-inspection reconstructionEvidenced review
- 21 CFR PART 11Upgrade regression summaries, applicability assessments, and controlled standard changes close under Part 11 e-signatures with immutable historyMaintained state
Deep-dive product guides. How ProcessX satisfies the regulatory and platform mechanics behind this workflow on ServiceNow.
- CSA · Platform UpgradesValidating ServiceNow upgrades under CSA without freezing the platform
- GxP Scoping · Risk TieringAutomating GxP regulatory applicability and system risk scoping on ServiceNow
- Paperless CSA · TraceabilityPaperless CSA validation and live requirements-to-release traceability on ServiceNow
- Annex 11 §9 & §11 · ReviewsScheduled periodic evaluation and Annex 11 audit-trail review on ServiceNow
- Part 11 · Annex 1121 CFR Part 11 and EU Annex 11 controls on ServiceNow
Other workflow products
Each is a proven starting point, with its controls and evidence model already wired.
- Regulated ITSMValidated change, GxP incident, CMDB/CSDM governance, and training-gated access and review — governed and evidenced.
- GxP third-party riskRisk-tiered vendor intake, AI vendor assessment, qualification and quality agreements, and SaaS release and re-assessment workflows.
- GxP AI governanceAI use-case intake and GxP applicability, autonomy tiering and guardrail sign-off, model and prompt change control, and scheduled drift review.
- Digital qualityCAPA and nonconformance extensions, product hold visibility, controlled approvals, and audit-ready management views.
- Compliant intakeCase management, complaint and vigilance triage, post-market intake, and human-reviewed AI routing.
Bring us your hardest validated state workflow.
We'll walk through how it would run on your ServiceNow: governed, evidenced, and with AI only where you want it.
or email processx@usdm.com