AI Agents for GMP‑Grade Uptime & Compliance
Automate GMP documentation, accelerate deviations and CAPAs, and keep cleanrooms within spec with specialized maintenance copilots.
Critical Assets
Where compliance and availability matter most
Production Equipment
Mixers, reactors, and tablet presses. Agents track parameter drift, runtime anomalies, and maintenance intervals to keep validated equipment within specification.
Clean Room Systems
HVAC, HEPA filtration, and environmental controls. Agents monitor pressure differentials, temperature, and relative humidity with automated alarms for excursions.
Packaging Lines
Filling, blister, and labeling systems. Agents manage validated changeover procedures and post-changeover quality checks to prevent packaging errors.
Top Maintenance Challenges
Stringent GMP Documentation
21 CFR Part 211 mandates complete, traceable records of all maintenance activities: who did what, when, with what materials. Paper-based systems and disconnected tools create gaps that surface during FDA inspections as observations or warning letters.
Contamination Risk from Maintenance
Every maintenance intervention in a cleanroom or aseptic area is a potential contamination event. Technicians, tools, and parts must follow strict gowning and material transfer protocols. Uncontrolled maintenance creates batch rejection risk.
Equipment Validation Burden
Any change to a qualified piece of equipment - even a preventive maintenance procedure change - triggers IQ/OQ/PQ revalidation and change control review. This slows response times and creates a backlog of deferred improvements.
What Our AI Agents Do
GMP Documentation & Change Control
Generate EBR‑quality records with signatures, audit trails, and version control; manage change control end‑to‑end.
- Automatic evidence for PM/CM/Cal
- Linked deviations and CAPAs
- Workflowed approvals and versioning
Environmental & Calibration Intelligence
Monitor temp, RH, pressure differential; orchestrate calibration windows and traceability to standards.
- Cleanroom parameter alarms
- Calibration plans by usage/criticality
- Full traceability and audit readiness