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Product · QMS

Change Control, exactly as your SOP describes it — signed, sequenced and audit-ready.

OneXPro QMS turns your paper change control form into a guided digital record. Each section opens at its stage, waits on the right people, and is closed by the signature your form names — with nothing for an inspector to reconstruct.

Request a demo How it meets Part 11

The lifecycle

Twelve sections. One continuous, signed record.

Transcribed from a real pharmaceutical change control form: the same section numbers, titles and impact items, so a reviewer holding the paper form finds every box on screen.

  1. § 1

    Initiation

    A person with the Initiated By designation chooses the client, adds a note for QA and signs. The number is issued at that moment: client / CC / department / year / serial.

  2. § 1

    QA issuance

    Anyone with the Issued By designation reads the initiation and issues it. Only then does the initiating department see it and write the description, current state, proposed change, references and justification.

  3. § 2

    Impact assessment

    The QA-QMS Coordinator assesses the change against 32 impact items — documents, equipment, validation, regulatory, training and more — each Applicable or Not applicable, with the action required.

  4. § 3

    Department review

    Quality Assurance signs first and must; every other impacted department records what it noted and signs its own row. An optional Additional Information Sheet carries its own signature.

  5. § 4

    Classification

    The coordinator classifies the change as Major or Minor and allocates the target completion date.

  6. § 5

    Head QA approval

    Head QA records recommendations and approves or rejects. The decision on screen must match the decision in the signature.

  7. § 6

    Principal party

    For contract manufacturing, the change is sent to your client by a secure e-mailed link. They review sections 1–5 as a PDF and e-sign with a one-time code — no account needed.

  8. § 7–8

    Extensions & discontinuation

    Up to two justified extensions of the target date, each decided by Head QA — or a signed proposal to discontinue. Both can be signed Not applicable.

  9. § 9–12

    Implementation & closure

    Closing documents attached and reviewed, QA post-implementation review, the initiating department's review, and Head QA's final verification closes the record.

Capabilities

Everything QA needs to run the register.

Numbers you never type

Issued once by the server inside the signing transaction — per client, department and year — and never reused. A draft that is abandoned leaves no gap; a numbered record is never deleted, only discontinued.

Your flow, enforced

The company admin decides who fills each section and signs each box, by name or by designation. Approval boxes require a named signer. The server enforces it — not just the screen.

Department-scoped visibility

A change control is seen by its own department and the people it involves. Administrators see all. Another department's records simply aren't there.

Waiting on you

One calculation drives the dashboard, the register and notifications, so everyone sees the same answer to “what is this waiting for, and on whom?”. In-app and e-mail alerts when work becomes yours.

Target dates that hold

No closing past the target date without an approved extension. Overdue records are flagged on the dashboard and in reports.

Closing evidence

Revised and obsolete SOPs, training records and other closing documents are attached to the record, reviewed and signed one by one — and retained.

Paper-layout PDF

Download the record in your form's own layout — header and page numbering on every page, sections not applicable struck through — with the full audit trail appended.

Dashboard & reports

Open, overdue and closed counts, records by stage, department and classification, and CSV export of the register for management review.

AI drafting — optional

Turn rough notes into clear, SOP-style text for any box. AI only proposes: it refuses to invent document numbers, and a person reviews, edits and signs.

Compliance

Every signature means something — and says so.

Each electronic signature records who signed, their designation and department at that moment, what the signature means, and the date and time in your site's time zone.

  • Password re-entered for every signature; wrong attempts count toward lockout
  • Signed sections are frozen — later edits cannot touch them
  • Before-and-after values for every change in the audit trail
  • Audit trail exportable as CSV or JSON, and appended to every PDF
  • Signatures made soon after an administrator password reset are flagged for review

Validation package included

Ten controlled Word documents, versioned with the software, to start your computerised system validation:

  • Validation Plan
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Design Specification (DS)
  • Installation, Operational and Performance Qualification protocols (IQ / OQ / PQ)
  • Deviation Report
  • Traceability Matrix
  • Validation Summary Report

Built for

Everyone on the form has a place.

Initiators & departments

Raise a change for your own department, then write and sign your parts.

QA & QMS coordinators

Issue, assess impact, classify, review closure — from one register.

Clients (principal parties)

Review and e-sign through a secure link, without an account.

Head QA & management

Approve, verify and see where every change stands.

Bring us your change control form.

We'll show it running in OneXPro — your sections, your flow, your numbering.

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