GxP AI governance
AI is arriving inside validated SaaS platforms, native ServiceNow releases, and internal builds faster than spreadsheet inventories can govern it. ProcessX adds the GxP compliance layer on ServiceNow — turning every AI use case, model update, prompt change, and agent boundary into a signed, audit-trailed workflow with validation evidence attached.
Part 11 e-signatures from System Owner and Quality on approved scope
Inspection only. The example record and its signature state stay unchanged.What ships in GxP AI governance
AI use-case intake and GxP applicability, autonomy tiering and guardrail sign-off, model and prompt change control, and scheduled drift review.
AI intake and GxP applicability
One ServiceNow front door for platform-native, vendor-embedded, and internal AI use cases — recording the workflow it touches, the regulated data it reads, the decision it informs, and a signed GxP applicability determination.
Autonomy tiering and guardrail sign-off
Each GxP use case is tiered by impact and autonomy level, locking in required human-in-the-loop review gates, prohibited actions, and CSA verification criteria before anything is enabled in production — extending ServiceNow AI governance with Part 11 controls.
Model, prompt, and release change control
Foundation-model swaps, prompt revisions, configuration updates, and AI features arriving in SaaS or ServiceNow upgrades route through controlled change with regression evidence before reaching regulated users.
Performance, override, and drift review
Scheduled operational reviews capture override rates, exceptions, and model drift on the ServiceNow record — with signed decisions to maintain, narrow scope, re-verify, or retire the AI capability.
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
- C1No AI use case is approved for GxP production without a signed applicability and risk-tier record
- C2Permitted scope, human review gates, and prohibited actions recorded per use case
- C3Model versions, prompts, and AI configurations restricted to validated change control
- C4Part 11 signatures and immutable audit trail on every approval, scope change, and periodic review
Evidence produced
- E1Live, inspectable register of GxP AI use cases, system owners, models, and approved boundaries
- E2Risk rationale and CSA verification evidence linked directly to the use case record
- E3Controlled change history and regression results for every model, prompt, or vendor AI update
- E4Signed periodic review outcomes tracking human override rates, incidents, and drift
What FDA AI credibility, EU Annex 11, and Part 11 expect of GxP AI
Current FDA and European regulatory frameworks evaluate AI by specific Context of Use — requiring documented risk tiering, explicit human-in-the-loop decision boundaries, change control over models and prompts, and ongoing drift oversight. ProcessX turns each requirement into a signed ServiceNow record rather than an unenforceable policy slide.
- FDA AI CREDIBILITYEach AI capability records its exact Context of Use, GxP data sources, decision influence, and risk-based verification plan before production enablementSigned scope
- ANNEX 11 / EU AIAutonomy tiers lock in mandatory human review gates, prohibited actions, and operational drift and override monitoring on a scheduled cadenceHuman oversight
- 21 CFR PART 11Electronic signatures and regulated state transitions remain strictly bound to re-authenticated people; AI assists in drafting or routing and never approves or signsPeople sign
- FDA CSA CHANGEFoundation-model swaps, prompt revisions, and platform or vendor AI releases route through validated change control with targeted regression evidence attachedChange-gated
Deep-dive product guides. How ProcessX satisfies the regulatory and platform mechanics behind this workflow 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.
- 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.
- 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 GxP AI governance 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