Lab Quality. Starting with OOS / OOT.
Verixa Phase 1 covers GMP. Structured OOS / OOT investigations are a Phase 2 cohort module, and broader lab and data-integrity coverage is on the roadmap — a direction we are building, not a live module today.
This page describes a roadmap commitment. Express interest to help the founding cohort define the priorities.
What Teams Face Today
OOS / OOT Investigations
Out-of-specification and out-of-trend results handled in paper trails and email, with no structured workflow tying result to investigation to disposition.
Manual Data Transcription
Relying on paper or disconnected spreadsheets instead of structured, traceable data capture for lab results.
Instrument Disconnects
Test instruments generating isolated data that requires manual stitching and verification.
Audit Vulnerabilities
Preparing for inspections takes weeks because lab records lack an integrated audit trail.
Where Verixa Is Headed
Structured OOS / OOT Workflows
A Phase 2 cohort module targeting out-of-specification and out-of-trend investigations — result, investigation, RCA, and disposition in one traceable flow. Cohort-defined, not yet live.
Data-Integrity Direction
On the roadmap: timestamped records and electronic-signature workflows under 21 CFR Part 11-aligned controls. Verified under our SDLC; the customer validates intended use.
Connected Lab Records
A planned path to link instrument data, deviations, and CAPAs — reducing manual transcription and stitching across systems.
Inspection Support
Roadmap goal: secure access to integrated lab records during inspections, with evidence built into each record as it is created.
Structured OOS / OOT Workflows
A Phase 2 cohort module targeting out-of-specification and out-of-trend investigations — result, investigation, RCA, and disposition in one traceable flow. Cohort-defined, not yet live.
Data-Integrity Direction
On the roadmap: timestamped records and electronic-signature workflows under 21 CFR Part 11-aligned controls. Verified under our SDLC; the customer validates intended use.
Connected Lab Records
A planned path to link instrument data, deviations, and CAPAs — reducing manual transcription and stitching across systems.
Inspection Support
Roadmap goal: secure access to integrated lab records during inspections, with evidence built into each record as it is created.
Help Define Lab OOS / OOT
OOS / OOT investigations are a Phase 2 cohort module, and broader lab coverage is on the roadmap — not a live module today. Tell us about your lab operations to help the founding cohort set the priorities.