ProcessX by USDM Life Sciences adds validated GxP workflows to your ServiceNow instance, with 21 CFR Part 11 and Annex 11 controls built in. Validated change, GxP incidents, periodic and access reviews, and the evidence that keeps your systems validated all run on the platform you have already invested in.
YOUR PLATFORMNo new platformRuns on the ServiceNow you already license, run and staff
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
Built on ServiceNow21 CFR Part 11EU Annex 11GAMP 5 / CSA900+ life sciences organizations served by USDM
PX-REC-01 · INTAKE · 1 OF 5
Start with the workflow you can't get wrong.
Validated change, GxP incidents, periodic reviews, deviations and CAPA: the regulated work where a missed step becomes an inspection finding. With AI in the loop, the bar on control goes up, not down.
CHANGEValidated change on GxP systemsIT · Quality
INCIDENTIncidents raised against validated systemsIT · Quality
REVIEWPeriodic, user access and audit trail reviewsSystem owners · Quality
CAPADeviations and corrective actionsQuality
INTAKEComplaints and post-market intakeQuality · Safety
RELEASEProduct hold and release decisionsManufacturing
PX-REC-02 · THE TEAM · 2 OF 5
Our engineers work inside your team.
USDM engineers sit with your IT, Quality and process owners and build the workflow with you. They stay until it runs in production under your Quality system. Not a ticket queue, and not an app you install and figure out alone.
ITYour ServiceNow owner: platform fit, CMDB/CSDM, accessBuilds with us
PROCESSYour process owner: how the work actually runsOwns the workflow
PX-REC-03 · THE PLATFORM · 3 OF 5
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
Four proven starting points, each with its controls and evidence model already wired.
Choose a workflow. Trace what happens and what it leaves behind.
a validated change where AI, configured for this customer, drafts the impact assessment and Quality signs.
Complete in example
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 and Quality approval
C4
Immutable audit trail on every regulated state transition
Evidence left behind
E1
Impact assessment linked to the change record it justifies
E2
Test and regression results bound to the release
E3
Reviewer attestations carrying identity, timestamp, and meaning
E4
Change evidence gathered on the change 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, 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.
User access review
Provisioning, de-provisioning, and scheduled access reviews run as controlled workflows with signed reviewer attestations on the record.
Awaiting signature — Quality Assurance
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.
A 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.
GxP DEVIATION · DEV0004127QA SIGN-OFF
Illustrative recordChoose a step or evidence row to inspect
STEP 03 · SignCurrent in example
Part 11 e-signature with meaning
Inspection only. The example record and its signature state stay unchanged.
Awaiting signature — Quality AssuranceMeaning: Approval · Re-authentication required · Hash-chained on signingAWAITING SIG
Illustrative record: a deviation where AI, configured for this customer, drafts and Quality signs.
PX-REC-05 · IN PRODUCTION · 5 OF 5
Released, validated, and run under your Quality system.
Validation and evidence are wired in from the first build. USDM can then run and improve the workflows under managed operations, so they never become another internal burden.
DEPLOYFirst GxP workflows in production6–12 weeks
USDMLife sciences organizations served900+
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.”
Digital workflow visibility for product release and quality events
Manufacturing and quality operations · anonymized
Controlled workflow automation improved visibility, review speed, and inspection readiness across manual quality processes.
PX-REC-06 · NEXT
Next: PX Agents, always on.
A GxP-hardened team of AI agents that never clocks out. They work inside your ServiceNow, the source of truth, reading and writing the same governed records your people use: drafting changes and evidence, routing work, catching drift at 3 a.m. And they run under the same controls as everything above. Each agent is released like a validated change, every action lands in the audit trail, and every regulated decision still 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
05:50EVIDENCE AGENTLinked 214 test results to release REL-2207Package ready for review
06:15INTAKE AGENTClassified 18 overnight complaints, 2 flagged for medical reviewReviewer can override
Illustrative: one night of the always-on agent team we are building toward.
SOURCEYour ServiceNow records stay the source of truth, never a shadow copyRead and write, 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.
