Built for the people who will scrutinize it.
Before a single demo, your QA, IT, and validation teams do their due diligence. This page is for them — how we handle your data, how we fit your validation and Part 11 obligations, and how a qualified human stays accountable for every AI output.
Your data stays yours
The first question every IT and QA reviewer asks. The answer is simple: your documents and data are never used to train shared models, and you stay in control of where they live and how long they're kept.
Never used to train models
Your proprietary documents, batch data, and deviations are not used to train shared or third-party foundation models. Your data works for you, not for anyone else.
Deployment & residency
Flexible deployment and data-residency options to meet your regional and corporate-policy requirements (US / EU / India and others by arrangement).
Data minimization
A proprietary data-minimization technique limits what the model sees to the evidence a task needs — reducing exposure and constraining the AI to your sources.
Encryption & access
Encryption in transit and at rest, role-based access control, and configurable retention. SSO and customer-specific controls available per deployment.
Designed to fit how you validate
ReveonAI is built to sit inside a risk-based CSV/CSA approach and support your data-integrity obligations — not to create a new compliance headache.
CSV / CSA & GAMP 5
Aligns with a risk-based, GAMP 5 computerized-system-assurance approach. We provide documentation to support your IQ/OQ/PQ and validation effort.
21 CFR Part 11 & Annex 11
Designed to support electronic-records obligations: attributable, time-stamped audit trails and reviewable records. E-signature and approval workflows configurable per deployment.
Audit trail & traceability
Every AI suggestion and every human action is logged, attributable, and reviewable — and each output is traceable back to the source evidence it was built from.
ALCOA+ data integrity
Outputs are structured to uphold ALCOA+ principles — attributable, legible, contemporaneous, original, accurate, and complete — under human review.
The human is accountable — always
Our entire design assumes the AI is a powerful assistant, never the decision-maker. That's the approach regulators expect, and it's how we keep AI output defensible.
- Human-in-the-loop on every output. Nothing is released by the AI alone. A qualified person reviews, edits, and signs — and remains accountable for what's used.
- Grounded, not open-ended. The data-minimization technique constrains the model to your provided evidence rather than free-form generation, reducing hallucination at the source.
- Traceable claims. Outputs are structured so a reviewer can trace each statement back to its source — making review fast and defensible.
- No autonomous regulatory action. ReveonAI drafts and flags; it never submits, approves, or closes a record on its own.
"Can your AI produce a wrong investigation?"
The honest answer: any AI can generate an imperfect draft — which is exactly why a person reviews and owns every result. We reduce the risk with grounding and data minimization, and we make review fast with full traceability. The combination is what makes the output safe to use in a GMP environment.
Where we are — stated plainly
We'd rather tell you exactly where we stand than imply certifications we don't yet hold.
- SOC 2 / ISO 27001: not yet certified — these are on our roadmap. In the meantime we complete customer security questionnaires and support your vendor due-diligence in full.
- Security questionnaires: we'll complete your standard IT/InfoSec assessment and provide architecture detail under NDA.
- Validation support: documentation and SME support to help your team validate ReveonAI within your QMS.
- Grounded team: guided by senior pharma quality, validation, GMP, and ex-FDA expertise on our advisory panel.
Send this to your security team
We'll share our security & compliance documentation — architecture, data handling, and validation support — complete your questionnaire, and walk your IT, QA, and validation stakeholders through it under NDA.