© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
Working only with trusted data, respecting roles, permissions, and audit trails, while drawing on everything your organisation knows, across every function, in one place.
External AI moves your data outside your compliance boundary. In regulated environments, that’s not a workflow problem, it’s a fundamental incompatibility.
One foundation. Cross-functional intelligence.
| Dimension | CARA AI (built-in) | Bolt-on AI | Generic LLM |
|---|---|---|---|
| Where your data goes | ✓ Stays in CARA | Copies out | Sent out by default |
| Who can see what | ✓ Role / object-aware | ~ Partial | None |
| Proving compliance | ✓ Lineage + audit trail | ~ Thin logs | None |
| Time to value | ✓ Seconds / Minutes | Months | Experiments |
| Risk profile | ✓ Low (no exports) | Data movement | High (data / IP) |
| Breadth | ✓ Any function across R&D, Reg, Safety, Quality, Clinical | Narrow | Generic text |
| Integrations | ✓ CARA + Enterprise systems | ~ Varies | Ad hoc |
One governed AI layer across Safety, Clinical, Regulatory, and Quality
Regulatory
See how regulatory teams use CARA to manage submission content, automate document assembly, and stay inspection-ready across every market.
Explore Regulatory →Safety
Watch how safety teams process ICSRs, manage PBRERs, and maintain full audit lineage, without stitching together disconnected tools.
Explore Safety →Quality
Watch how Quality Directors use CARA to manage the full GxP document lifecycle, reduce overdue reviews, and close the loop on corrective actions faster.
Explore Quality →Clinical
See how clinical teams keep eTMF, protocol documents, and site records aligned, with the traceability and access controls inspectors expect.
Explore Clinical →PBRER highlights without reading 60 pages
Audit reports distilled to what actually matters
100 pages of trial data — clear insights today
Variation narratives and submission documents — not from scratch
PBRER first drafts and RMP annexes from live data
SOPs and CAPAs — first drafts in minutes, not days
Patient narratives and CSR sections — consistently formatted
Label changes checked against your PSMF, RMP, and submission history in one pass
Signal trends across your portfolio — spotted, not missed
Protocol deviations across sites — at a glance
Health Authority query patterns — anticipated before they arrive
Benefit-risk signals surfaced before reporting deadlines
Recurring deviations flagged before they compound
Data lock risks visible weeks before they delay timelines
Submission dossiers in local formats — without starting over
RMP annexes for multiple markets — technically consistent
SOPs across countries — technically accurate, no rework
ICFs in multiple languages — medically accurate across markets
PBRER highlights without reading 60 pages
Audit reports distilled to what actually matters
100 pages of trial data — clear insights today
Variation narratives and submission documents — not from scratch
PBRER first drafts and RMP annexes from live data
SOPs and CAPAs — first drafts in minutes, not days
Patient narratives and CSR sections — consistently formatted
Label changes checked against your PSMF, RMP, and submission history in one pass
Signal trends across your portfolio — spotted, not missed
Protocol deviations across sites — at a glance
Health Authority query patterns — anticipated before they arrive
Benefit-risk signals surfaced before reporting deadlines
Recurring deviations flagged before they compound
Data lock risks visible weeks before they delay timelines
Submission dossiers in local formats — without starting over
RMP annexes for multiple markets — technically consistent
SOPs across countries — technically accurate, no rework
ICFs in multiple languages — medically accurate across markets
Spend your time driving results, not drowning in documentation
Lower audit exposure with provable lineage
Faster cycles across teams; fewer handoffs
Lower cost per change/submission; fewer surprises
Each function has a dedicated page with deeper use cases, implementation detail,
and outcome evidence.
Deploy CARA AI for one function today. When a second function is ready, they join the same platform no new vendor, no new validation, no new RFP process.
Use case:
A label comparison that also checks safety signals. A CAPA that surfaces related deviations across sites. A submission that draws from clinical, regulatory, and quality content simultaneously. These use cases only exist on a unified platform.
Regulatory, Safety, Quality, or Clinical. Each delivers immediate value on its own from day one.
Same platform. Same validation. Same vendor. A second function joins the foundation, it doesn’t integrate with it. No new RFP required.
The more functions on the platform, the more your AI can do. With use cases that simply don’t exist on any other architecture.
Widely regarded by our customers for our responsiveness, we offer unprecedented care and attention to deliver a high-performing platform for all your needs. CARA now counts over 1,000,000 users across industries worldwide, including 8 of the 10 largest Life Science companies.
60%
of top pharma
1M+
Users
99.9%
Uptime SLA
25+
Years in regulated life sciences
24/7
Expert Support
Built on a platform that enterprise pharma already trusts
CARA AI runs on the same unified foundation already deployed across the world's leading pharmaceutical companies. The platform that makes this AI possible has been proven in production, at scale, under inspection, across every major life sciences function.
© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved