Deviation Detected
Deviation identified and logged with classification, severity, and impacted batch or process. Automatic routing to the responsible quality owner.
GMP Core · Phase 1In Design-Partner Validation
Deviation to CAPA. One Unbroken Thread.
From deviation detection to root cause to corrective action — every decision traceable, every AI inference and human approval captured as a first-class GxP object in the audit trail.
Phase 1 ships GMP Core — six workflows, in design-partner validation. Verified under our SDLC; the customer validates intended use.
21 CFR Part 211
EU GMP Annex 11
21 CFR Part 11
Annex 22 (Draft 2025)
SHA-256 audit trail
The Challenge
What GMP Quality Teams Face Today
Regulatory complexity is rising while QA resources stay flat.
Manual Deviation Tracking
Paper-based or fragmented systems that lose context between identification, investigation, and resolution.
Weeks of Audit Prep
QA teams spend weeks assembling compliance evidence that should be generated continuously, not retroactively.
Disconnected Quality Records
Deviations, CAPAs, findings, and training records managed in separate systems with no traceability.
The AI Evidence Gap
Legacy audit trails don’t capture model version, prompt hash, retrieved evidence, or the human decision behind AI-assisted work.
Use Case Walkthrough
Closed-Loop Workflow
From deviation detection to verified closure — every step documented and traceable.
Investigation Initiated
Root cause analysis using 5-Why, fishbone, or fault tree. Evidence attached, timeline documented, and investigation plan reviewed.
Root Cause Confirmed
Investigation conclusions reviewed and approved by QA. Contributing factors identified, documented, and linked to the originating deviation.
CAPA Created
Corrective and preventive actions assigned with owners, due dates, and acceptance criteria. Automatically linked to the source deviation.
Actions Implemented
CAPA tasks executed, evidence collected, and implementation verified against pre-defined acceptance criteria by the task owner.
Effectiveness Verified
Post-implementation review confirms the root cause is fully addressed. Trend analysis updated. Loop closed with full audit trail.
Phase 1 · GMP Core
Six Workflows · In Design-Partner Validation
Each workflow captures model version, prompt hash, retrieved evidence, the HITL gate, and the e-signature as first-class GxP objects.
1
Four-tier libraries, versioning, review cycles, and controlled distribution — every change captured in the audit trail.
Document Control
2
Classification, severity, investigation, and closure — with MIRA surfacing gaps for a qualified human to disposition.
Deviation
3
5-Why, fishbone, and fault-tree methods. MIRA suggests angles and cites evidence; a human decides.
Root Cause Analysis
4
Corrective and preventive actions with owners, due dates, effectiveness verification, and e-signature.
CAPA
5
Inspection and audit findings tracked to closure, linked to the evidence that resolves them.
Findings
6
The G-7 evidence pack assembled continuously, so readiness is a state — not a fire drill.
Inspection Readiness
Honest Status
What’s Built, In Verification, and On the Roadmap
The full Module Feature Matrix is available to founding partners as a gated download.
Built6
Phase 1 · architecture-completeDocument Control
Deviation
Root Cause Analysis
CAPA
Findings
Inspection Readiness
In Verification4
Phase 1 · design-partner phaseSchema-level audit trail
e-signature substrate
MIRA advisory + HITL guardrails
HITL decision gates
Phase 2 Hardening8
2027 Q2–Q4Change Control
OOS / OOT
Audit Management
Supplier Quality
APQR
Batch Records
Training
Mock Inspection
Phase 3 Future5
2028+GDP / Cold Chain
GCP / Clinical Quality
GVP / Pharmacovigilance
Stability
Environmental Monitoring
Informed By
The Standards We Design Against
Compliance is a customer determination based on intended-use validation — not a vendor claim.
21 CFR Part 211
Current Good Manufacturing Practice for finished pharmaceuticals.
EU GMP Annex 11
Computerised systems — operational reference for GMP IT controls.
21 CFR Part 11
Electronic records and electronic signatures — audit-trail and e-signature controls.
EU GMP Annex 22 (Draft 2025)
AI/ML in GMP — treated as an internal-control reference.
FDA CSA Final Guidance (Feb 2026)
Risk-based computer software assurance informs our approach.
MHRA Data Integrity (ALCOA+)
Data-integrity expectations across the record lifecycle.
WHO TRS No. 996 Annex 5
Guidance on good data and record-management practices.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.