The next layer of quality intelligence.
ClariSure Intelligence is being developed as an AI-enabled environment designed to help Life Sciences organizations interpret requirements, evaluate documentation, connect evidence, identify gaps and risks, and prioritize compliance actions — with qualified human review before anything becomes a conclusion.
Analysis that ends with a person, not a score.
Applicability of any regulation or standard to a specific product, process or organization must be determined by qualified professionals. ClariSure Intelligence is being designed to support that determination with traceable analysis — not to make it.
In development
What is being built
Requirements
Identify applicable regulations and standards, extract requirements, compare across frameworks, and detect conflicting requirements.
Documentation
SOPs, policies, protocols, validation reports, technical files and risk management files analyzed clause by clause.
Analysis
Evidence mapping, gap identification, missing-evidence detection, compliance and risk scoring, and change-impact assessment.
Output
Prioritized corrective action recommendations, compliance matrices, executive dashboards and audit-readiness reports — each traceable to source.
Planned library coverage includes FDA, ISO, ICH, EU MDR, EU IVDR, IEC, GMP, GxP, GLP, GCP, GDP and additional frameworks. Coverage described here is planned scope, not delivered functionality.
Planned architecture
- Tenant isolation
- Encryption in transit and at rest
- Role-based access controls
- Audit logging
- Source traceability for every output
- Human approval before conclusions
- Client ownership of client data
- Configurable retention
- Secure document handling
These describe the planned architecture of a product in development. ClariSure does not currently hold SOC 2, ISO/IEC 27001 or HIPAA attestations and makes no such claims. Certification status will be published when achieved.
Help shape it.
Early access opens to a limited group of quality and regulatory leaders whose use cases will inform what gets built first. Joining places you under no obligation and costs nothing.
Early access opens to a limited group whose use cases will shape what gets built first. Request it through our consultation page and mention ClariSure Intelligence — include your industry, current QMS platform and the use case you care about most.