MIRA is the Verixa quality copilot
Advisory. Human-in-the-loop. Never autonomous in GxP-critical decisions. MIRA surfaces gaps, drafts evidence, and cites its sources — and a qualified human accepts before any GxP impact.
Verified under our SDLC; the customer validates intended use. Every inference and every human decision is captured as a first-class GxP object in the audit trail.
MIRA whitepaper is gated — requested via the team.
An assistant for your QA team — not a decision-maker
MIRA accelerates the work of surfacing, drafting, and evidencing. The judgment stays with your qualified reviewers, and the decision evidence is logged.
Surfaces gaps
Reads your GMP records and surfaces gaps, inconsistencies, and missing evidence for a human to review.
Drafts deviation summaries
Drafts deviation summaries and narratives that your QA team edits, accepts, or rejects.
Suggests CAPA actions
Suggests CAPA actions and root-cause angles — as suggestions, never as decisions.
Cites the source evidence
Every suggestion is grounded in retrieved evidence, with the source cited for the reviewer.
Logs the full inference
Logs model version, prompt hash, and retrieved evidence on every inference it runs.
Captures the human decision
Your accept / reject / modify decision and e-signature are captured as first-class GxP objects in the audit trail.
The hard lines around GxP-critical decisions
MIRA does not approve, close, sign, dispose, or release any GxP record.
MIRA does not write to a GxP field without your explicit accept.
MIRA does not make critical GMP decisions — batch release, OOS classification, CAPA disposition.
MIRA is never the sole path for a critical GMP decision. A qualified human is always in the loop.
The control documents behind MIRA
MIRA is governed by a documented set of controls, available to founding partners as a gated download. Each defines how the model is used, assured, and changed.
Request the MIRA architecture pack- AI Governance V7 Plan
- Provider Assurance Pack
- Intended Use Statement
- Acceptance Criteria
- Change Control rules
Designed against the standards taking shape now
EU GMP Annex 22 (Draft 2025)
Treated as an internal-control reference — generative AI prohibited from sole-path critical GMP decisions.
EU AI Act (Reg. 2024/1689)
Role-specific, obligation-specific. Phasing in 2026–2027. Verixa makes no claim of EU AI Act compliance.
FDA CSA Final Guidance (Feb 2026)
Risk-based, critical-thinking approach to computer software assurance informs our design.
GMLP — Good Machine Learning Practices
Good Machine Learning Practice principles guide model lifecycle and oversight.
21 CFR Part 11 audit-trail extension
AI inferences and human decisions extend the electronic audit trail as first-class records.
Compliance is a customer determination, not a vendor claim. Verixa provides the architecture and evidence; the customer validates intended use under its own quality system.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.