Continuous evidence for ANVISA inspections.
Temperature, humidity and pressure records with an immutable trail, ready for inspection and for the ONA or JCI survey.
DROME turns manual monitoring-data collection into continuous regulatory evidence, ready for inspection at any time.
Requirement by requirement.
Click each regulation to see how DROME addresses each requirement specifically.
RDC 430Distribution, Storage and Transport of Medicines
Good practices for the distribution, storage and transport of medicines. Calls for qualified and validated systems, calibrated instruments, thermal qualification and temperature control during storage and transport.
DROME logs 100% of readings, generates automatic reports and documents each excursion with timestamp, user and corrective action.
What does RDC 430 require for temperature monitoring?
RDC 430/2020 requires calibrated instruments placed according to the area's thermal qualification, monitoring records kept for at least 2 years (Art. 43) and temperature control during storage and transport (Art. 84). DROME logs readings continuously and documents each excursion with its corrective action.
RDC 50 + NBR 12188Medical Gas Installations
RDC 50/2002 is ANVISA's technical regulation for the physical design of healthcare facilities, including medical gas installations. ABNT NBR 12188 covers centralized medical gas and vacuum systems, with pressure alarms and periodic checks of the pipeline.
DROME logs pressure per supply source and per riser, sends real-time alerts and keeps the history of alarms and maintenance for each point in the pipeline.
Which standards apply to a Brazilian hospital's medical gas pipeline?
RDC 50/2002 sets the physical design of healthcare facilities, including medical gas installations. ABNT NBR 12188 covers centralized gas systems, with pressure alarms and periodic checks. DROME logs pipeline pressure and keeps the history of alarms and maintenance.
ONA / JCIHospital Accreditation
ONA (Brazil's National Accreditation Organization) and JCI (Joint Commission International) assess how environments, equipment and medicines are controlled during the accreditation survey.
Unified dashboard with a compliance score per area, non-conformity reports and an exportable history of corrective actions.
How does continuous monitoring help with ONA or JCI accreditation?
During the survey, ONA and JCI check that environments, equipment and medicines are under documented control. DROME shows the history per area, non-conformity reports and recorded corrective actions.
Ready to simplify your compliance?
DROME turns manual monitoring-data collection into continuous regulatory evidence, ready for inspection at any time.