What we monitor
The equipment that keeps your batches compliant
Production Equipment
Reactors, mixers, granulators, and tablet presses. Temperature monitoring, calibration tracking, and performance qualification.
Clean Rooms
ISO-classified environments with stringent particle and microbial controls. Environmental monitoring, HEPA filter tracking, and entry/exit protocols.
Packaging Lines
Blister packing, bottle filling, and serialization systems. Line speed monitoring, reject rate tracking, and changeover validation.
Sound familiar?
GMP documentation demands
Every maintenance activity must be documented with full traceability. Missing a calibration log, skipping a step, or using the wrong form can trigger a deviation that takes weeks to resolve and puts batches at risk.
Clean room contamination risk
Maintenance activities in clean rooms introduce contamination risk. Entry protocols, gowning procedures, and tool sterilization must be followed precisely, and every step must be documented.
Constant requalification burden
Equipment changes, repairs, and even routine maintenance can trigger requalification requirements. Tracking which equipment needs revalidation and managing the paperwork is a full-time job.
How Dovient works
An AI copilot that understands GMP requirements, clean room protocols, and equipment qualification
Dovient connects to your existing equipment, CMMS, and quality systems. The AI agents learn your facility's patterns and proactively manage the work your team shouldn't have to do manually.
GMP-compliant maintenance documentation with audit trails
Every work order, calibration record, and maintenance activity is documented with full traceability. Electronic signatures, timestamps, and change history are captured automatically.
Calibration records generated automatically with full traceability.
Clean room entry protocols and contamination prevention
The system manages entry/exit procedures, tracks gowning compliance, and logs all maintenance activities within classified environments. Contamination risk is minimized through guided procedures.
Clean room maintenance logged with entry/exit timestamps.
Equipment qualification and calibration tracking
IQ, OQ, and PQ status is tracked for every piece of equipment. Calibration due dates, validation expiry, and requalification triggers are managed proactively.
Equipment requalification triggered proactively, not reactively.
Change control integration for validated systems
Maintenance activities that affect validated systems are flagged automatically. Change control records are generated with impact assessments and approval workflows.
FDA audit prep reduced from weeks to hours.
Outcomes
What changes in your first 90 days
Calibration records filled in by hand, sometimes after the fact
Calibration records generated automatically with full traceability and electronic signatures
Clean room maintenance logged inconsistently
Clean room maintenance logged with entry/exit timestamps and gowning verification
Equipment requalification triggered reactively after auditor findings
Equipment requalification triggered proactively based on maintenance and change history
FDA audit prep takes weeks of record gathering
FDA audit prep reduced from weeks to hours with always-current documentation