What we monitor
The controlled environments your products demand
Clean Rooms
Particle counts, temperature, humidity, differential pressure. Excursions documented automatically with deviation workflows.
Production Equipment
Qualification status, calibration tracking, maintenance records. IQ/OQ/PQ documentation generated and linked to each asset.
Quality & Testing
In-process testing, final inspection, sterility assurance. Trend analysis for process capability and quality indicators.
Sound familiar?
Every audit is a fire drill
FDA announces an inspection and your team drops everything to compile records from paper files, Excel sheets, and multiple systems. Weeks of prep for information that should be at your fingertips.
QMSR changed the rules
Transition from 21 CFR 820 to QMSR aligned with ISO 13485 doubled your documentation. Your existing QMS was built for the old regulation. Gap analysis reveals holes everywhere.
Cybersecurity is now required
FDA requires cybersecurity documentation for connected devices. 35% cite it as their top emerging risk, yet most lack systems to track controls continuously.
How Dovient works
Validation from weeks to minutes
Connects to your QMS, equipment systems, and production data. Maintains continuous compliance documentation, automates validation workflows, keeps you audit-ready at all times.
Automated IQ/OQ/PQ validation
Qualification protocols generated, executed, and documented automatically. Full traceability, no manual assembly.
Equipment validation from weeks to minutes.
Continuous audit readiness
CAPAs, deviations, change controls, training: all maintained in real-time. When an auditor arrives, documentation is current, complete, and instantly retrievable.
Always audit-ready. No preparation scramble.
eDHR automation
Electronic Device History Records built from production data. Every batch record, in-process check, and release test captured without manual entry.
DHR built automatically from production data.
QMSR gap analysis
AI maps current documentation against QMSR requirements continuously. Gaps identified, prioritized by risk, tracked through closure.
Gaps found proactively, not during audits.
Outcomes
First 90 days
Validation takes weeks of manual documentation
IQ/OQ/PQ automated with full traceability. Minutes, not weeks
Audit prep requires weeks of record compilation
Continuous readiness. All records current and retrievable
DHR assembled from paper and spreadsheets
eDHR built automatically from production data
QMSR gaps discovered during audits
Gaps identified proactively, tracked through closure