AIra.
AI-powered batch readiness, scheduling, and decision intelligence across sterile injectables and oral dosage forms.
Soon at aira.airavance.com
“Is this batch truly ready?” No CDMO can answer that today.
CDMOs coordinate batch readiness across 10 functions using 50–200 Excel trackers, daily stand-ups, and 40–80 email chains per batch. The result: 15–40% of batches face preventable delays costing $50K–$500K each. AIra unifies documents, materials, equipment, facilities, personnel, QC methods, QA approvals, packaging, and validation into one intelligent readiness engine — and predicts risk before it derails the schedule.
Ten dimensions. One readiness score.
AIra unifies every function involved in batch preparation into a single live picture.
Batch
Batch records, MBRs, and execution checklists verified before start.
Document
SOPs, BMRs, and controlled documents approved, versioned, audit-ready.
Material
Raw materials, APIs, excipients, and components released and staged.
Equipment
Calibration, cleaning, maintenance, and qualification status verified.
Facility
Rooms, utilities, environmental monitoring, and line clearance confirmed.
Personnel
Trained, qualified, and gowning-certified operators scheduled.
QC
Methods validated, samples planned, instruments and reagents ready.
QA
Approvals, deviations, and change controls cleared for execution.
Packaging
Components, labels, artwork, and serialization data verified.
Validation
Process, cleaning, and computer system validation status current.
One readiness engine. Every function.
Batch Readiness Management
Ensure all components, documentation, and resources are prepared before production begins — across every function.
Real-Time Tracking
Monitor readiness status across departments with live dashboards and a single source of truth.
Compliance & Documentation
Maintain regulatory compliance with automated checks, audit-ready records, and 21 CFR Part 11 controls.
Workflow Automation
Reduce manual errors by automating critical preparation processes, escalations, and Go/No-Go gates.
Predictive Insights
Leverage AI-driven analytics to identify risks 2–4 weeks ahead and prevent client-impacting delays.
Connects MES, LIMS, ERP, QMS
Bidirectional integrations layered onto your existing stack — no rip and replace, no parallel system.
From reactive firefighting
to proactive readiness.
Cut preventable batch delays and lost revenue with earlier visibility into readiness gaps.
Align Operations, QC, QA, Supply, and Engineering on one shared readiness picture.
Automated checks and audit trails keep every batch inspection-ready by default.
Live dashboards replace status meetings, spreadsheets, and email chains.
Predictive insights give leaders confidence at every Go/No-Go gate.
Built for regulated manufacturing.
CDMO Manufacturing
Sterile injectables and oral dosage facilities running multi-client, multi-product schedules.
Biotech Firms
Clinical-stage and commercial biotech teams managing batch execution across internal and partner sites.
Pharmaceutical Organizations
Branded and generic pharma operations driving readiness, compliance, and on-time release at scale.
Designed alongside Quality & Operations teams who live the readiness problem every day.
Connect. Track. Predict.
AIra integrates seamlessly into your existing systems, centralizing all batch preparation activities into one intelligent platform.
Connect
AIra integrates with your MES, LIMS, ERP, and QMS — centralizing batch preparation data without ripping out existing systems.
Track
Live readiness dashboards unify documents, materials, equipment, personnel, QC, and QA across every function and team.
Predict
AI flags client-impacting risks 2–4 weeks ahead and structures Go/No-Go decisions with audit-ready trails.
Replace Excel chaos with
decision intelligence.
Pilot AIra at your site.
We're partnering with select CDMOs ahead of public launch — sterile and oral dosage facilities welcome.