ANVISA · BRAZIL

Automated ANVISA compliance.

RDC 430, RDC 722 and RDC 50 in real time, no spreadsheets.

DROME turns manual monitoring-data collection into continuous regulatory evidence, ready for inspection at any time.

RDC 430
Fully covered
RDC 722
Fully covered
RDC 50
Medical gases
ONA + JCI
Hospital accreditation
100%
Immutable audit trail
REGULATIONS COVERED

Every article. Every requirement.

Click each regulation to see how DROME addresses each requirement specifically.

RDC 430
Drug Storage
Fully supported

Requires continuous temperature and humidity monitoring with automatic logging, alarms and periodic reports for cold rooms and controlled environments.

Art. 8Continuous monitoring with automatic logging of temperature and humidity.
Art. 9Configurable alarms for deviations outside the approved range.
Art. 12Monthly reports with the complete history of readings.
Art. 15Documented action plan for each recorded excursion.
Art. 18Periodic sensor calibration with traceability to INMETRO.
How DROME complies

DROME logs 100% of readings, generates automatic reports and documents each excursion with timestamp, user and corrective action.

RDC 722
Good Distribution Practices
Fully supported

Governs the transport and storage of medicines with temperature control across the entire logistics chain.

Art. 6Temperature control during storage and transport.
Art. 11Electronic records with electronic signature and audit trail.
Art. 14Qualification of refrigeration equipment.
Art. 16Documented procedures for temperature deviations.
How DROME complies

Immutable audit trail, electronic signature of compliance and documented qualification of every monitored equipment.

RDC 50
Medical Gases
Fully supported

Establishes requirements for the production, storage and distribution of medical gases, including pressure and purity monitoring.

Art. 7Continuous pressure monitoring across the distribution network.
Art. 9Alarms for pressure drops below operational limits.
Art. 12Records of O₂, N₂O and medical air concentration.
Art. 15Preventive maintenance with documented history.
How DROME complies

Pressure, concentration and flow sensors with real-time alerts and a complete history for each network point.

ONA / JCI
Hospital Accreditation
Fully supported

ONA (Brazilian National Accreditation Organization) and JCI (Joint Commission International) require documented environmental control across the entire facility.

ONA Level 2Monitored and documented environmental control in critical areas.
ONA Level 3Risk analysis and continuous improvement based on monitoring data.
JCI EC.02.05Inspection, testing and maintenance of equipment and infrastructure.
JCI MM.05Storage of medicines under safe and controlled conditions.
How DROME complies

Unified dashboard with a compliance score per area, non-conformity reports and an exportable history of corrective actions.

Ready to simplify your compliance?

DROME turns manual monitoring-data collection into continuous regulatory evidence, ready for inspection at any time.

FDA · 21 CFR Part 11European Union · EU GMP Annex 11
ANVISA Compliance | DROME — RDC 430, RDC 722 and RDC 50 automated