From batch to release: AI that keeps pharma manufacturing compliant

Deviation management and CAPA

Catch deviations against validated batch parameters in real time, and route root cause analysis and corrective and preventive action (CAPA) documentation without slowing the line.

Batch release delays

Unify LIMS, MES, and ERP data into one governed, real-time view, so batch record review doesn't wait on manual reconciliation across systems.

Line clearance and changeover

Guide operators through line clearance, cleaning, and changeover with step-by-step digital work instructions, reducing contamination risk and changeover time.

Asset reliability for critical utilities

Predict failures on HVAC, water-for-injection systems, and clean utilities before they force an unplanned shutdown or a batch loss.

Audit readiness and electronic batch records

Keep every execution detail, signature, and deviation traceable in a single electronic batch record (EBR), so audit prep doesn't mean weeks of paper reconciliation.

Skills gaps and workforce

AI copilots and guided work instructions put process expertise in front of every operator, so tools fit existing validated workflows instead of fighting them.

Predictive asset intelligence

Predict failures on critical utilities, HVAC, and clean-in-place systems with remaining-useful-life modeling, and automate maintenance dispatch before assets fail.

Batch process optimization

Monitor critical process parameters against validated ranges in real time, and get closed-loop advisories that improve yield without reopening a validation package.

Quality intelligence and deviation management

Forecast in-process quality issues, automate CAPA routing, and trace out-of-specification (OOS) root causes with LIMS and batch genealogy integration.

Digital work instructions and line clearance

Guide operators through line clearance, changeover, and cleaning validation with step-by-step digital instructions and instant sign-off.

Audit readiness and electronic batch records

Keep execution data, signatures, and deviations traceable in a single EBR, so audit prep runs continuously instead of once a year.

Industrial DataOps

Unify OT and IT data across sites into a single namespace with 100+ connectors, and build a Cortex graph purpose-built for pharmaceutical operations.

Agentic operations with IRIS Flows

Run autonomous agents from anomaly to root cause to work order, auto-respond to deviations, and coordinate multi-agent batch scheduling with a human always in the loop.

AI copilot for plant and quality operations

Ask natural-language questions over batch and quality data, capture operator advisories and shift handover reports, and search SOPs instantly.

Browse apps and agents for pharma

See the IRIS Foundry apps and agents already built for pharmaceutical and life sciences operations, from batch quality management to CIP/SIP monitoring. Need something else? IRIS Forge builds it from a prompt.