For Quality Operations

Your quality operations.
Audit-ready.
Without the reactive firefighting.

CARA manages your full Quality function on one governed platform — QMS, SOPs, change controls, deviations, and CAPAs. Add CARA AI when you’re ready, and the work changes: drafting time drops by 50–80%, deviation trends surface before they escalate, and change control impacts are mapped automatically.

• Data never leaves CARA

• Full audit trail on every AI output

• One validation scope — total

• Permissions apply automatically

For architecture, model transparency, and technical governance detail — See full AI Overview →

Your Quality team's expertise is going on documentation management. Not on preventing risk.

SOPs get drafted from scratch every cycle. Change controls trigger manual impact assessments across systems your team has to chase individually. Deviation trends sit buried in spreadsheets until they surface as audit findings.

Most AI tools sit on top of that same fragmented foundation. Your team still has to chase the source, reconcile records, and govern outputs separately. You’ve added a tool. You haven’t removed the problem.

CARA AI works from inside your Quality data, not on top of it. The documentation burden disappears. Your team gets back to quality oversight.

Built on unified Regulatory data

Trust, control, confidence by design

Productivity that was impossible before

The numbers that matter to Quality

50 - 80%

SOP, CAPA, and risk assessment drafting time reduction

Automatic

Change control impact mapping across QMS

0 Reactive audit surprises — continuous readiness by default

Early

Deviation and complaint trends surfaced before escalation

GENERATE

SOPs and CAPAs drafted before your team starts writing

Writing a new SOP or CAPA used to mean starting from a blank template. CARA AI produces first drafts from existing Quality documentation — consistently structured, traceable to source, ready for review not creation from scratch.

Manual drafting → 80% faster

COMPARE

Change control impacts mapped across your QMS. Automatically.

A global policy update used to mean manually identifying every conflicting SOP, work instruction, and training record. CARA AI detects conflicts and maps impacted documents simultaneously — before the change goes live, not after.

Manual cross referencing → Mapped automatically

PREDICT

Deviation trends surfaced before they become findings

Individual deviations look isolated. Patterns across your QMS don't. CARA AI analyses deviations and complaints continuously to surface systemic risks early — so your team acts before the pattern becomes an audit finding.

Reactive review → Early intervention

Quality capabilities

CARA AI Section

What your team sees

One governed AI layer across Regulatory, Safety, Quality, and Clinical,
full traceability on every output.

Context-aware search

Surfaces regulatory precedents and clinical correlations that keyword search misses.

Automated classification

Every document tagged, categorised, and enriched automatically. Instant retrieval, every time.

Pre-tuned for compliance

Built-in prompts for regulatory workflows. Accurate from day one, customisable further.

Your LLM

Choose the model that fits. All processing stays in our secure framework. Your IP stays yours.

Data extraction

Pulls structured data from messy PDFs and clinical reports. Analysis-ready in seconds.

Schedule a demo AI Playlist

Source citations

Linked to the exact platform record

Full audit trail

Every action logged in the sidebar

Human review

Built into every workflow step

What becomes possible when all
your data is on one platform.

CARA AI runs on one platform. One validation scope.The AI capabilities extend what the platform already does,
no separate system, no separate contract, no separate validation cycle.

The more of your operations run on CARA, the more your AI can do. Regulatory, Safety, Quality, and Clinical on one platform means AI that works across your entire function not just in silos.

REGULATORY

For Regulatory Affairs & Reg Ops

Draft. HA query responses in 20 minutes

Generate. Submission dossiers from live data

Compare. Labels across all markets in 1 minute

SAFETY

For Pharmacovigilance & PV teams

Generate. PSMF from live data, 3 weeks to minutes

Draft. PBRER and DSUR across your safety layer

Monitor. Signal detection across your full PV data

QUALITY

For QA Managers & Quality Operations

Draft. SOPs and quality docs 50-80% faster

Detect. Change control, regulatory variation trigger

Audit. Full trail on every AI-generated output

CLINICAL

For Clinical Operations & eTMF leads

Structure. eTMF AI classification and completeness

Inform. Regulatory submissions from eTMF data

Review. Trial master file gaps surfaced automatically

60%
of top pharma

1M+
Users

99.9%
Uptime SLA

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.

25 +

Years in regulated life sciences

24/7

Expert Support

— PLATFORM ARCHITECTURE

One platform. One validation scope. No governance gaps.

Bolt‑on AI generates content in isolation. CARA AI generates it from your live, governed regulatory content with a complete audit trail, all within your current governance framework, without extra tools, exports, or revalidation.

HA Q&A answered in minutes — not days

A Health Authority query draws on live submission records, Safety data, and Quality records in a single response. No cross-system data pull. No manual reconciliation. One platform, one governed layer.
Metric: 2–5 days → 20 minutes
Label beneath metric: Based on internal benchmarks

Your quality operations.Audit-ready.Without the reactive firefighting.