Roles · Quality Manager

Dozens of decisions wait on you.Each one arrives with its evidence.

CAPAs, change controls, deviations and audit findings reach you in one queue, each with its evidence and the thread behind it. You decide from the record and sign under 21 CFR Part 11.

Watch an audit run

The same seat, by other titles

  • Quality Manager
  • QA Manager
  • Director of Quality
  • Head of Quality
  • Quality Director
The seat

You hold six roles on the record.

The disposition and the SOP carry your signature. You sponsor the strategic change, run the CAPA when there is no one else to, lead the audit and own the product-quality risk.

Where it breaks

You answer for the programme. The same findings keep coming back.

Each case closes on its own. The pattern across cases, the slipped effectiveness check and the finding nobody owns never reach a queue, so the next audit finds them again.

  1. The same defect, a new CAPA numberThe pattern across cases is in the data, never in the workflow.
  2. Effectiveness checks slipA target date with no gate, so the CAPA closes and the problem stays.
  3. Audit findings stall at the ownerThe finding sits in the report and the action in nobody's queue.
  4. Management review, built by handEvery quarter the time goes into the report, not the question.
Closed twice, back a third time. The pattern was in the data, never in anyone's queue.

Every repeat investigation is paid for twice. That is the coordination tax.

Measure your coordination tax →
The difference

Every finding leaves the audit with an owner and its evidence.

The annual ISO 13485 audit, from your queue to your sign-off: each finding recorded against its clause, routed to CAPA with its context, and tracked to closure where you can see it.

Customer proof

Quality leaders, in their own words.

The people who run quality, on what changed when their decisions, audits and approvals moved onto one record.

Quality on Unifize

Bring the decision that has waited longest.

In thirty minutes we run it on one record: the evidence, the thread and your Part 11 signature, end to end.