Modules · Change Control (PLM/ECR)

Change nothing
by accident.

Change Control gives every change — an engineering change, a document revision, a part or BOM update — one controlled path from request to proof. See what a change touches before you approve it, route it for e-signed sign-off, control when it takes effect, and keep the whole QMS in step. Because TLM is two apps on one system, people raise and approve changes in a browser while your quality team owns the workflow.

ECR/ECO · impact assessment · approvals · effectivity

Two engineers reviewing a technical drawing to assess a proposed change
Under control
✓ impact assessed · e-signed · verified
Request → approve → implement
What Change Control does

From request to proof — nothing changes off the record.

One path for every change

Engineering changes, document revisions, part and BOM updates all run the same request → review → approve → implement flow — no side channels, no email chains.

Impact assessment up front

See what a change affects — documents, parts, training, suppliers — before you approve it, so nothing downstream slips through the cracks.

Approvals with e-signatures

The right reviewers sign off, and every decision is recorded to 21 CFR Part 11 — the same integrity layer under the rest of TLM.

Effectivity & rollout

Control when a change takes effect, and confirm it actually landed everywhere it had to — not just that someone approved it.

Ripples across your QMS

A change flows to documents, training, CAPAs, and inspections — and TLM keeps them in step, so an approved change doesn’t leave stale records behind.

A complete change history

Who changed what, when, and why — the traceable trail an auditor opens first, built automatically as the change moves.

The dual-app advantage

One system. Two apps. The right tool for every person.

TLM runs as a deep desktop/network Main App and a modern browser Web App on one shared database. Your quality team owns the change workflow; everyone else just raises and approves.

Main App Depth & control
Quality managers · engineering · admins
  • Configure change types, workflows, and approval routing
  • Define impact rules and effectivity / rollout control
  • Link changes to documents, parts, BOMs, and training
  • The complete, controlled change record of truth
  • Evidence packages for FDA / notified-body audits
Web App Reach & simplicity
Everyone · reviewers · approvers · remote
  • Raise a change request from any browser, from anywhere
  • Review, approve, and e-sign without printing a thing
  • See exactly what a change affects before you sign
  • Live dashboards: my approvals, open changes, overdue
  • Modern web reports — change velocity, backlog, schedule email alerts

Same data, same system — pick the front door that fits the person.

The AI advantage · TLM, multiplied by Claude

Know what a change touches — before you make it.

Ask Claude to assess a proposed change against your controlled documents and records — what it affects, what needs re-approval, what training it triggers — so impact analysis takes a sentence instead of an afternoon with a spreadsheet.

See TLM, multiplied by Claude →
One connected system

The hub every change runs through.

Change Control sits at the center of your QMS: a released document, a corrective action, a supplier change, a part revision — each moves through the same controlled request-and-approval path, protected by electronic signatures and the audit trail, so nothing changes without a record and nothing affected gets left behind.

See it live

Bring us the change you’re nervous to make.

The one with a dozen downstream effects you’re afraid to miss. In a 20-minute demo we’ll show you the controlled path — impact assessed, approved, and verified — with the record already built.

Request a Demo →

One of our friendly account reps will be assigned to your account and can walk you through it · No credit card

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