CARA replaces a point solution function-for-function, a fully capable QMS, RIM system, or PV platform. The difference is the architecture underneath. When you’re ready to bring on a second function, the data is already there. Regulatory draws from the same records Quality already manages. Safety draws from the same product data Regulatory uses. No integration project, no data migration the platform grows with you without the overhead of connecting separate systems.

No. A single-function deployment is a complete outcome in its own right. The architecture supports expansion when you’re ready, but nothing about starting with one function obligates you to go further.

Scope drives effort. A single-function deployment is a different undertaking from a multi-function rollout with legacy migration behind it. We work through the as-is/to-be model with you, architecture, data migration, validation, support, and total cost of ownership — sized against your environment, not a generic estimate.

Two paths. If you’re experiencing multi-vault fatigue, escalating licensing costs, or an approaching contract renewal, displacement is the conversation. If Veeva is staying, CARA connects alongside it via a native Veeva connector, adding a unified AI and governance layer without a rip-and-replace. The right path depends on your contract position and how many Vaults your teams work across.

Migration follows a structured five-stage process: extract content, metadata, and audit trails from your existing system; analyse what maps to CARA; enrich and standardise the data for import; validate in a controlled environment with full documentation; then load to production with a final delta migration at go-live. Content, metadata, and audit trails are preserved throughout.

CARA runs on AWS infrastructure with multiple geographic deployment options, including private cloud for organisations requiring greater control over data hosting. Backups replicate across separate geographic regions. Multi-jurisdiction specifics are best discussed directly — requirements vary by organisation and regulatory market.

CARA provides documented evidence that the base platform has been built and tested to a defined standard, materially reducing the validation burden on your side. Your own user acceptance testing and risk assessment remain your responsibility; proportionate to the processes you’re running. Any vendor claiming to eliminate that obligation entirely is not being accurate.

Every action in CARA, who accessed a record, what changed, and when — is captured automatically as part of normal use. The audit trail covers document changes, user actions, workflows, version histories, and data lifecycles. The evidence exists when the question is asked, not assembled under pressure.

CARA is ISO/IEC 27001:2022 certified. The platform is configured to support 21 CFR Part 11 and GxP compliance, with aligned controls built into every workflow, automated audit trails, access controls, and encryption at rest and in transit. Annual independent penetration testing validates the security framework. Security documentation is available on request.

CARA enables your teams to interact with regulated documents and records using natural language. When a user asks a question, CARA builds a context-aware prompt combining the relevant document content or record details, the user’s question, and system instructions — so the AI responds based on your organisation’s actual governed data, not general knowledge. Multiple LLMs are supported. All interactions run inside the platform’s regulated environment, data never leaves the controlled boundary, and every AI interaction is captured in a full audit trail. Using those same models outside a governed platform means regulated data exits the controlled environment with no traceability — that is a compliance gap, not a technical preference.