Quality Risk Management Software
Risk grounded in history.

ICH Q9-aligned FMEA and HACCP, informed by your own failure history.

Risk Assessment module in the Lead AI Platform
Supported workflowQuality Risk Management

Why teams come
to us for this.

Risk workshops run on estimates — even when your records already show which failures happened, and how often.

  • Risk discussions backed by organisational history
  • Method and evidence kept with the assessment
  • An attributable decision, not an automated one

Quality risk management tools for the pharmaceutical industry.

01

ICH Q9 risk management support

Structured around the risk question and a documented method.

Risk Assessment — ICH Q9 risk management support
02

FMEA and HACCP workflows

FMEA, HACCP and other methods supported — the system never picks or approves the method.

Risk Assessment — FMEA and HACCP workflows
03

Historical failure retrieval

Past failure modes and occurrence retrieved to inform the discussion.

Risk Assessment — Historical failure retrieval
04

Named risk decision

AI organises, scores and flags. Accepting risk stays human.

Risk Assessment — Named risk decision

Built for

Quality risk managementQuality assuranceSubject-matter experts

The rest of the Quality & Manufacturing

Want Risk Assessment running on your data?

Tell us the process or prediction you need. We'll map it to a module, a deployment and an honest timeline.

Bring your challenge.
Let’s find the right next step.

Request a Free Data Assessment

Leave your details and someone from the team will be in touch.

Interested inPick one or more

We'll only use this to reply about your enquiry.