Product guides · ServiceNow GxP architecture & evidence
How regulated work holds up on ServiceNow.
Technical reference notes written from the workflow and record level: what 21 CFR Part 11, EU Annex 11, FDA Computer Software Assurance (CSA), and current AI guidance expect, where unconfigured ServiceNow falls short, and how ProcessX produces inspection-ready evidence inside your instance.
Guides by regulatory and platform question
Each guide maps regulatory expectations directly to ServiceNow architecture, workflow controls, and the audit records your Quality team defends at inspection.
- 21 CFR Part 11 and EU Annex 11 controls on ServiceNowWhy native ServiceNow approvals fail §11.50 and §11.200 at inspection, and how ProcessX enforces hash-chained e-signatures, authority checks, and immutable audit trails.21 CFR Part 11 · EU GMP Annex 11 · ALCOA+ Data Integrity · Predicate Rules (GMP / GCP / GLP)
- Validating ServiceNow upgrades under CSA without freezing the platformHow scoped-app architecture, pre-validated ProcessX releases, and targeted CSA regression keep ServiceNow current without semi-annual validation gridlock.FDA CSA Guidance (2022) · GAMP 5 (2nd Edition) · 21 CFR Part 11 · EU Annex 11 (§4 & §11)
- Governing AI on ServiceNow in GxP workflowsHow to isolate regulated ServiceNow records from platform-wide AI, introduce drafting or routing one workflow at a time, and satisfy FDA context-of-use expectations.FDA Draft Guidance on AI Credibility (2025) · 21 CFR Part 11 · EU Annex 11 & EU AI Act Oversight Principles · FDA CSA Guidance
- Assessing embedded AI in validated SaaS and GxP vendors on ServiceNowWhy vendor "GxP-ready AI" claims do not transfer compliance, the six criteria every GxP AI supplier audit needs, and how to govern quarterly SaaS AI releases on ServiceNow.21 CFR 211.84 & 820.50 (Purchasing / Suppliers) · EU Annex 11 (§3 Suppliers & Service Providers) · ICH Q9 & Q10 · FDA AI Credibility & CSA Guidance
Built on one validated GxP layer.
- Definition
- ProcessX is a GxP workflow layer for ServiceNow from USDM Life Sciences, adding 21 CFR Part 11 and EU Annex 11 controls, pre-built regulated workflows, governed AI assistance, and audit-ready validation evidence.
See the workflows these guides cover
Six pre-built workflow families give USDM engineers a validated starting point inside your ServiceNow tenant.
- Regulated ITSMValidated change, GxP incident, CMDB/CSDM governance, and training-gated access and review — governed and evidenced.
- Validated stateApplicability assessment, periodic and audit trail review, GxP standard change, and an app validated on every release.
- 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 regulated workflow.
Pick the one with the most at stake. In a working session we'll walk through how it would run on your ServiceNow: governed, evidenced, and with AI drafting where it helps.
or email processx@usdm.com