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Regulated ITSM

IT and Quality on one ServiceNow platform, with the change, incident, configuration, and access workflows regulated systems actually require — and the evidence to prove each one ran correctly.

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GxP CHANGE · CHG0041287QA 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 validated change where AI, configured for this customer, drafts the impact assessment and Quality signs.
PX-REC-01 · WHAT SHIPS

What ships in regulated ITSM

Validated change, GxP incident, CMDB/CSDM governance, and access review — governed and evidenced.

  • 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.

PX-REC-02 · CONTROLS AND EVIDENCE

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

  1. C1Part 11 and Annex 11 electronic signatures with recorded signature meaning
  2. C2Re-authentication at the point of signing
  3. C3Role-based segregation between IT execution and Quality approval
  4. C4Immutable audit trail on every regulated state transition

Evidence produced

  1. E1Impact assessment linked to the change record it justifies
  2. E2Test and regression results bound to the release
  3. E3Reviewer attestations carrying identity, timestamp, and meaning
  4. E4Change evidence gathered on the change record as work happens, not reconstructed before an audit
PX-REC-03 · FIELD RESULT

Regulated ITSM cycle time cut from 70 days to 17.5 days

Abbott · ServiceNow COE

IT, Quality and Validation run change, incident and release on one governed ServiceNow platform, with traceability built in and fewer manual review steps.

“Choosing ProcessX to enhance our ServiceNow investment was the right decision.”

Robert Sklenar, Senior Manager, ServiceNow COE, Abbott
PX-REC-04 · CONTEXT · USDM.COM

The regulatory thinking behind these workflows

USDM publishes the regulatory point of view behind these workflows — why generic ITSM falls short under GxP, and what inspectors expect instead.

PX-REC-05 · OTHER WORKFLOW PRODUCTS

Other workflow products

Each is a proven starting point, with its controls and evidence model already wired.

Bring us your hardest regulated ITSM workflow.

We'll walk through how it would run on your ServiceNow: governed, evidenced, and with AI only where you want it.

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