ReguRisk AIQuality risk management
Turn risk analysis into actionable intelligence.
An AI-assisted workspace for structuring risk assessments, identifying potential failure modes and documenting risk-based decisions.
Interactive prototypeInteractive preview below
⚙ Aperçu d’interface ReguRisk AI · fourni par le thème, textes dans assets/js/i18n
The problem
Risk assessments can turn into scoring exercises.
Spreadsheets capture numbers, but the rationale behind each score and the follow-up often get lost.
Subjective scores
Different people rate the same failure mode differently.
Lost rationale
The reasons behind scores are not recorded.
Weak follow-up
Mitigations are listed but rarely tracked to closure.
Proposed workflow
From failure mode to documented decision
How the module is designed to fit into daily work.
Define scope
Process, system or change under assessment.
Identify
Potential failure modes and their effects.
Score
Severity, occurrence and detectability, with rationale.
Mitigate
Actions proportionate to the risk.
Review
Decisions documented and revisited.
Interface preview
Adjust a risk score
Pick a sample failure mode, move the sliders and watch the matrix and priority update.
Interactive previews powered by sample content. No AI model, regulatory database or external system is connected. Names, records and values are fictional.
⚙ Démo interactive ReguRisk AI · fourni par le thème, textes dans assets/js/i18n
Capabilities
What it does, and what is still planned.
Each capability shows its current status.
Interactive risk matrix
Severity and occurrence plotted live.
Interactive prototype
RPN calculation
Severity × occurrence × detectability, with illustrative thresholds.
Interactive prototype
Session log
Record scored items during a session.
Interactive prototype
FMEA support
Guided identification of failure modes and effects.
Planned
Rationale capture
Prompts to justify each score.
Planned
Mitigation tracking
Actions, owners and status.
Planned
CAPA risk follow-up
Links between risks, CAPA and change control.
Future roadmap
Use cases
Who it helps, and how.
Validation engineerRisk-based qualification scope
Decide where testing effort matters most.
Process ownerAssess a change
Score the impact before implementing a process change.
QAPrioritise CAPA
Focus resources on the highest risks.
Human oversight
Scores and thresholds in ReguRisk AI are inputs to a decision. Your quality risk management procedure defines the method, scales and acceptance criteria, and qualified people own the decision.
Related modules
Works well with
Want to see it with your own workflows?
Request a demo or join the pilot programme.