AI Module · Risk Management
Risk management that works across your every product, team, and location
Generate, review, and manage safety, cybersecurity, and process risks in a single integrated workspace within ins2outs. Leverage AI, saving 75% time on initial generation and up to 50% on updates.
How Risk Management works in ins2outs
Structure and traceability, without the spreadsheet overhead
The Risk Management module brings structure, collaboration, and compliance to different risk types, locations, and products, all within your existing eQMS.
Create a risk file from scratch or copy an existing one
Edit and filter risk records in a familiar table view
Review, approve, and sign your risk files with full version control
Comment, mention, assign tasks directly inside risk files
Trace every risk to documents, CAPAs, and audit records
Use ready-made risk templates, or configure your own
Export to Excel or PDF for external reporting and submissions
What risk management module covers
Manage risks smarter in one integrated workspace
Safety risks
Identify hazards, assess severity and probability, and document every control decision.
Cybersecurity risks
Track threats and document controls across your product portfolio as exposure evolves after launch.
Process risks
Capture and manage process risks across teams, sites, and locations with consistent org-wide criteria.
Your custom risk type
Define a risk process tailored to your organisation’s context.
The Risk Management module brings structure, collaboration, and compliance to different risk types, locations, and products, all within your existing eQMS.
Risks link bidirectionally to SOPs, product documentation, non-conformities, and audit findings. This is what makes the module audit-ready by design: every version, every approval, every change is logged and accessible without manual reconstruction.
Every risk links directly to the documentation that supports it — requirements, IFU, instructions, and process records — so nothing exists in isolation.
Get maximum from AI capabilities in research and data mapping
%
time saving on initial risk generation
%
time saving on updates and ongoing maintenance
The Risk Management module includes AI-powered risk file generation.
You provide the device purpose and product specs, and AI generates a structured initial risk file aligned to relevant standards. For maintenance, AI handles routine update work with a human-in-the-loop step at each stage to review and confirm the output.
Drive consistent innovation with a structured foundation for AI governance
Risk management is one module inside ins2outs, a compliance platform that covers quality, information security, AI management, and data privacy in a single connected environment.
Risk Management
- A Standard or Premium Plan is required for AI Modules
Standard
- One organization
- Public cloud configuration
- Customizable workflows
- User Access and Management
- Import and Export KPIs, Report and Stats
- Mapping to Standards and Regulations
- User Compliance tracking
- 5h of onboarding support
Premium
- Everything in Standard +
- Slack support channel
- Multi-Factor Authentication
- SSO over SAML2
- CFR part 11 compliance
- Integrations (Slack, Teams, GitLab, OpenAI etc.)
- Risk management, requirements, traceability
See the risk management module in action
Book a 30-minute demo and we’ll walk you through risk file generation, traceability, and the AI wizard with your product context in mind.