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Digital quality

Quality events, holds, and approvals as governed workflow instead of email and spreadsheets — visible to the people who must act, and evidenced for the people who audit.

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CAPA · CAPA-0187QA SIGN-OFF
Illustrative recordChoose a step or evidence row to inspect
STEP 03 · ApproveCurrent in example

Part 11 e-signature on the corrective action

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 CAPA where AI, configured for this customer, drafts the investigation and Quality approves it.
PX-REC-01 · WHAT SHIPS

What ships in digital quality

CAPA and deviation extensions, product hold visibility, controlled approvals, audit-ready dashboards.

  • CAPA / deviation extensions

    Quality events extend the same controlled workflow engine, so investigations and corrective actions carry the same evidence discipline as regulated IT work.

  • Product hold visibility

    Holds surface against the affected product, batch, and systems, rather than living in one person’s inbox until someone asks.

  • Controlled approvals

    Approvals carry signature meaning, re-authentication, and role segregation wherever a quality decision is made.

  • Audit-ready dashboards

    Open events, aging, and closure evidence in one view — the view you can show an inspector without preparing for a week.

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 signatures on quality decisions
  2. C2Segregation between investigation, approval, and closure
  3. C3Immutable history of every state change and comment
  4. C4Configurable retention aligned to record type

Evidence produced

  1. E1Investigation record linked to the affected product and systems
  2. E2Approval chain with identity, timestamp, and meaning
  3. E3Closure evidence attached to the event, not to a mailbox
  4. E4Trend and aging views built from the records themselves
PX-REC-03 · CONTEXT · USDM.COM

The regulatory thinking behind these workflows

The manufacturing and quality context behind these workflows — Pharma 4.0, GMP, and the Part 11 baseline — is published 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 digital quality 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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