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Validated state

ProcessX arrives validated, and each ProcessX release is validated. The recurring work that keeps GxP systems validated (deciding scope, periodic and audit trail review, low-risk change) runs as governed workflow instead of documents and spreadsheets.

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PLATFORM UPGRADE · CHG0052140QA SIGN-OFF
Illustrative recordChoose a step or evidence row to inspect
STEP 03 · SignCurrent in example

Part 11 e-signature on the test summary

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 ServiceNow upgrade where USDM runs the regression on your validation instance and your Quality signs before production.
PX-REC-01 · WHAT SHIPS

What ships in validated state

Applicability assessment, periodic and audit trail review, GxP standard change, and an app validated on every release.

  • Regulatory applicability assessment

    A documented, approved decision on whether each system is GxP. The same assessment can record whether a system has AI capabilities to assess before they touch a regulated process.

  • Periodic and audit trail review

    Reviews scheduled, assigned and evidenced for every GxP system, with overdue work visible, and audit trail reviews with outcomes you can report instead of reconstruct.

  • GxP standard change

    Pre-approved, controlled standard changes for low-risk work on validated systems, so routine changes stop waiting on the full change process.

  • Validated on every release

    Each ProcessX release is validated, so you verify your own intended use and configuration instead of validating a custom build. As an optional USDM service, when you upgrade ServiceNow, USDM runs the automated regression package on your validation instance and hands your Quality the results to review and sign before you move to production.

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 on assessments and review outcomes
  2. C2Review schedules and owners enforced by the workflow
  3. C3Standard changes limited to pre-approved, controlled templates
  4. C4Immutable audit trail on every assessment, review and decision

Evidence produced

  1. E1A documented, approved GxP determination for every system
  2. E2Periodic and audit trail review outcomes on the system record
  3. E3Validation evidence for each ProcessX release
  4. E4Regression results from each upgrade, reviewed and signed by your Quality
PX-REC-03 · CONTEXT · USDM.COM

The regulatory thinking behind these workflows

USDM has run validation for life sciences for 25+ years. Its thinking on applicability, periodic review and risk-based assurance lives on usdm.com.

PX-REC-04 · OTHER WORKFLOW PRODUCTS

Other workflow products

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

Bring us your hardest validated state 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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