Describe the change
Examples
How it decides
- Classify. Claude (or the offline keyword model) maps the text to a change type in the versioned rule catalogue and extracts stated facts.
- Look up. Registrations, sites, GMP evidence and ICH Q12 protocols come from RIM.
- Decide. Deterministic rules set each market's reporting category, with the citation.
- Gate. Low confidence, open facts or data conflicts route to an RA reviewer. Everything is logged.
Pick a product and describe a manufacturing or controls change. ChangeLens proposes the filing category for every market where the product is registered, with its source, and routes anything uncertain to a reviewer.
Assessments this session
Seeded history is shown on the Governance tab only.AI governance & data quality
Assessments per week
Proposed category mix
Most frequent change types
RIM data quality
Automated checks on the registration and site master data the assistant depends on. Each finding has an owner.
Controls in place
Model classifies, rules decideThe model can only pick from catalogue entries; categories come from a versioned rule pack with citations.
Conservative by defaultWhen a deciding fact is unknown, the strictest plausible category is shown as provisional.
Human in the loopConfidence below , open facts, or data conflicts route to an RA reviewer. Overrides need a reason.
Full audit trailAppend-only log of input hash, classifier and model, rule pack version, outputs and reviewer decisions.
Graceful fallbackIf the model is unavailable, an offline classifier runs and the fallback is recorded.
Aligned frameworksHuman oversight, transparency and traceability in the spirit of the NIST AI RMF, the EU AI Act and ISO/IEC 42001.
Rule library
Each change type maps to ordered rules per market. The first rule whose conditions match decides; rules blocked by an unknown fact make the result provisional.