For life sciences companies on ServiceNow
GxP compliance on the ServiceNow you already own.
ProcessX by USDM Life Sciences turns your ServiceNow instance into one governed platform for regulated work, with 21 CFR Part 11 and Annex 11 controls built in. Validated change, GxP incidents, access and periodic reviews, vendor risk, quality workflows, and intake run on the same controlled records — with governed AI enabled only where you choose.
- YOUR PLATFORMNo new platformRuns on the ServiceNow you already license, run and staff
- BEYOND QMSEnd to end or hybridRuns quality workflows end to end or alongside your DMS/LMS — plus the IT, vendor, AI, and intake work a standalone QMS never reaches
- VALIDATEDValidated appEach ProcessX release is validated, so you verify your intended use, not a custom build
- PART 11Audit-readyPart 11 and Annex 11 signatures, audit trail and review records, kept on the ServiceNow record
- AIOnly when you chooseRegulated work stays in a scoped app, apart from the AI each ServiceNow release adds
- DEPLOY6–12 weeksFirst GxP workflows in production, built by USDM engineers with your team
Start with the workflow you can't get wrong.
Standalone quality tools stop at one department's door, while regulated work crosses IT, Security, suppliers, manufacturing and support. Validated change, GxP incidents, periodic reviews, third-party qualification, deviations and intake belong on one governed platform — closing the email and spreadsheet gaps where inspection findings happen.
- CHANGEValidated change on GxP systemsIT · Quality
- INCIDENTIncidents raised against validated systemsIT · Quality
- REVIEWPeriodic, user access and audit trail reviewsSystem owners · Quality
- VENDORThird-party SaaS, AI, and GxP supplier qualificationIT · Security · Quality
- CAPADeviations, nonconformances and corrective actionsIT · Operations · Quality
- INTAKEComplaints, vigilance and post-market intakeSupport · Safety · Quality
- RELEASEProduct hold visibility across batch, lot, and release teamsManufacturing · Quality
Embedded in your team. Accountable for production.
USDM engineers embed with your IT, Quality, and process owners. They build and validate the workflow, chase down the decisions, access, and approvals it needs, and keep every team moving until your Quality signs it into production. Not advisors on a call, not a ticket queue, and not an app you install and figure out alone.
- ITYour ServiceNow owner: platform fit, CMDB/CSDM, accessBuilds with us
- QUALITYYour Quality lead: controls, validation review, approvalSigns
- PROCESSYour process owner: how the work actually runsOwns the workflow
- ARCHITECTUREYour enterprise architect: integrations across ERP, MES, LIMS, and clinical systems, where in scopeConnects the estate
They build on ProcessX, the GxP layer for ServiceNow.
- 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.
- PART 11Electronic signature with meaningHash-chained to the record
- AUDITAudit trail on every regulated state changeImmutable
- ACCESSRe-authentication and role controlsEnforced
- VALIDATIONRequirements, risk, testing and release evidenceLinked
Bigger than a QMS. The nexus for quality, risk, and compliance.
Operational systems such as ERP, MES, LIMS, DMS, LMS, and clinical platforms each run their own domain — and a standalone QMS only adds one more silo. Configured on ServiceNow, ProcessX becomes the governed operating layer across them: able to run quality workflows end to end or alongside your existing repositories while uniting IT, system validation, third-party risk, AI governance, and intake on one controlled record graph.
- QUALITYDeviations, nonconformances, CAPA, change control, product hold visibility, and configured supplier quality actions as governed ServiceNow recordsEnd to end or hybrid
- RISKSystem applicability, GxP AI governance, third-party SaaS and supplier qualification, and ongoing risk-tiered re-assessmentIT · Security · Quality
- COMPLIANCEValidated change, GxP incidents, CMDB/CSDM, training-gated access, and periodic and audit-trail reviews across regulated systemsAudit-ready by design
- ACROSS SILOSConnects regulated events, holds, and changes across enterprise systems — such as ERP, MES, LIMS, DMS/LMS, clinical, and safetyConnected across silos
- AGENT-READYOne controlled record layer so governed AI assistance — and future GxP agents — operate safely, one workflow at a timePeople always sign
Six pre-built workflow families. Validated starting points.
Each workflow family gives USDM engineers a validated foundation on ServiceNow — configured and extended with your team to fit the regulated processes your estate demands.
Choose a workflow. Trace what happens and what it leaves behind.
Illustrative record · GxP CHANGE · CHG0041287
Regulated ITSM
a validated change where AI, configured for this customer, drafts the impact assessment and Quality signs.
Impact assessment drafted from the linked configuration items
AI is off until USDM configures it for your workflow. This example shows it configured for a customer: AI suggests, a person decides, and AI never changes the record's state or signs.
Controls that apply
- C1
Part 11 and Annex 11 electronic signatures with recorded signature meaning
- C2
Re-authentication at the point of signing
- C3
Role-based segregation between IT execution, system ownership, and Quality approval
- C4
Provisioning and change-closure gates enforced on training status and linked SOP readiness
Evidence left behind
- E1
Impact assessment, affected procedures, and test results bound to the change and release
- E2
Training status at the moment of access approval preserved on the provisioning record
- E3
Reviewer attestations carrying identity, timestamp, and meaning
- E4
Change and access evidence gathered on the ServiceNow record as work happens, not reconstructed before an audit
See the 4 included workflows
- GxP incident
- Incidents raised against validated systems carry regulated fields, review steps, and closure evidence, so a production issue leaves an inspection-ready record instead of a ticket comment.
- Validated change
- Change requests route by GxP impact, collect assessment and test evidence as they move, hold closure where linked SOP or work-instruction updates in your DMS remain open, and close with Part 11 approvals bound to the release record.
- CMDB / CSDM governance
- Which systems are validated, what they depend on, and who owns them — maintained as governed configuration data rather than a spreadsheet nobody trusts at audit time.
- Training-gated access and review
- Access requests on GxP systems verify role-required training status from your connected LMS before provisioning, flag accounts when training lapses or roles change, and run scheduled access reviews with signed attestations on the record.
Meaning: Approval · Re-authentication required · Hash-chained on signing
Illustrative workflow, not a live system record. Selecting a step explores the example; it does not complete or approve work.
Read the full Regulated ITSM workflowA safe place for regulated work. AI only when you are ready.
Each ServiceNow release brings more AI into the platform, and not every team is ready to validate a whole platform with AI in it. ProcessX keeps your regulated workflows in a scoped, validated application, apart from the AI you turn on elsewhere on the platform, such as the help desk. Inside it, AI stays off until you decide where it helps. USDM then configures it for that workflow, and it goes live like any other validated change. You can move the dial one workflow at a time.
- OFFProcessX runs without AI: your people do every step and sign every decisionWhere you start
- DRAFTConfigured for your workflow: AI drafts impact assessments, change summaries and risk rationale from the linked recordsA reviewer edits and signs
- ROUTEConfigured for your workflow: AI suggests how to classify and route work, with reasoning a reviewer can seeReviewer confirms or overrides
- NEVERAt any setting, AI never approves, signs or changes a record's statePeople decide
Example · the DRAFT setting
An illustrative deviation workflow with AI configured to draft: AI prepared the impact assessment from the linked batch records, and Quality reviews, edits and signs it. Choose any step or evidence row to inspect it.
Part 11 e-signature with meaning
Inspection only. The example record and its signature state stay unchanged.Governing AI use cases, vendor models, and prompts across your wider GxP estate?Explore GxP AI governance
In production. Validated. Signed off by your Quality team.
ProcessX arrives validated by USDM and stays validated across every release, with evidence wired in from the first build. With managed operations, USDM runs assessments, periodic reviews, and ServiceNow upgrade regressions inside your instance while regulated approval gates stay with your Quality and process owners.
- DEPLOYFirst GxP workflows in production6–12 weeks
- RELEASESValidated across every ProcessX release, with managed upgrade regressionContinuous
Regulated ITSM cycle time cut from 70 days to 17.5 days
Abbott · ServiceNow COE
ProcessX put Abbott's IT and Quality change work on governed ServiceNow workflows, cutting initial deliverable cycle times by up to 75%.
“Choosing ProcessX to enhance our ServiceNow investment was the right decision.”
Fast ServiceNow adoption without building a validation machine
Arrowhead Pharmaceuticals
Pre-configured workflows, Part 11 approvals and validation helped Arrowhead meet its regulatory requirements as it moved onto ServiceNow.
“ProcessX was a big step forward in getting us on ServiceNow and ready for commercialization.”
Inside your ServiceNow security boundary.
ProcessX runs as a scoped application inside the ServiceNow tenant you already govern — never a separate cloud database, shadow copy, or uncontrolled AI pipe.
- DATARegulated records and evidence stay inside your ServiceNow instance — no external ProcessX database or shadow copyIn your instance
- ACCESSScoped application inheriting your enterprise SSO, ACLs, role segregation, and signing re-authenticationScoped & role-gated
- AUDITHash-chained Part 11 signatures and an immutable audit trail on every regulated state changeTamper-evident
- AIAI stays off by default, isolated from platform-wide ServiceNow AI, and enabled one workflow at a timeOpt-in only
Next: PX Agents, always on.
A GxP-hardened team of AI agents that never clocks out. Working inside your ServiceNow instance across IT, quality, vendor, and intake records, they correlate signals, draft changes and deviations, and link evidence at 3 a.m. — without ever approving, signing, or advancing a record's regulated state. Each agent is released like a validated change, every action lands in the audit trail, and every regulated decision waits for a qualified person's signature.
- 02:14CHANGE AGENTDrafted the impact assessment for CHG0041890 from 12 linked configuration itemsAwaiting QA signature
- 03:02DRIFT AGENTFound an unapproved configuration change on a GxP systemDeviation drafted
- 04:37ACCESS AGENTFlagged 3 dormant accounts in the quarterly access reviewRouted to system owner
- 05:12VENDOR AGENTFlagged an expiring vendor attestation and drafted a scoped re-assessmentQueued for QA review
- 05:50EVIDENCE AGENTLinked 214 test results to release REL-2207Package ready for review
- 06:15INTAKE AGENTClassified 18 overnight complaints, 2 flagged for medical reviewReviewer can override
- SOURCEAgents draft records and link evidence on ServiceNow — never a shadow copy, and never a regulated state changeDrafts & links, governed
- RELEASEEach agent is qualified and released like a validated changeSigned by Quality
- AUDITEvery agent action is recorded in the same audit trailImmutable
- DECIDERegulated decisions stay with a qualified personPeople sign
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