Built for the Quality Authority.
For the VP Quality, Head of Quality, and QA Director. Phase 1 GMP Core works alongside your team — drafting evidence and surfacing gaps, while the QA Authority retains decision rights on every GxP-impactful action. Founder-led through the design-partner phase by Vimal Veereshwarayya, PhD, RAC.
The Verixa Advantage
MIRA is advisory and human-in-the-loop — it drafts CAPA entries, deviation reports, and investigation summaries for QA to review and approve. It never decides; the Quality Authority does.
Deviation trending, training-gap analysis, and workflow monitoring across GMP sites. Issues are surfaced for review before they become findings.
Evidence and audit trails are built into each record as it is created — reducing audit-prep effort. Verified under our SDLC; the customer validates intended use.
Document Control, Deviation, RCA, CAPA, Findings, and Inspection Readiness in one Phase 1 GMP Core. Full cross-referencing, no manual linking.
MIRA is advisory and human-in-the-loop — it drafts CAPA entries, deviation reports, and investigation summaries for QA to review and approve. It never decides; the Quality Authority does.
Deviation trending, training-gap analysis, and workflow monitoring across GMP sites. Issues are surfaced for review before they become findings.
Evidence and audit trails are built into each record as it is created — reducing audit-prep effort. Verified under our SDLC; the customer validates intended use.
Document Control, Deviation, RCA, CAPA, Findings, and Inspection Readiness in one Phase 1 GMP Core. Full cross-referencing, no manual linking.
QA Teams
Phase 1 GMP Core — Document Control, Deviation, RCA, CAPA, Findings, and Inspection Readiness.
Deviation, RCA & CAPA
Structured GMP workflows for capturing deviations, conducting root-cause analysis, and managing corrective and preventive actions — with MIRA drafting investigation summaries for QA review at each step.
Findings & Inspection Readiness
Centralised findings management with evidence traceability so records carry their own audit trail. Verified under our SDLC; the customer validates intended use for FDA, EMA, or MHRA inspections.
Document Control & Training
Version-controlled SOPs, work instructions, and policies with training assignments. Ensure staff are trained on the current document before they execute a process.
Quality Visibility
Live dashboards surfacing open deviations, overdue CAPAs, and training gaps across GMP sites — so the Head of Quality sees risk before it becomes a finding.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.