Regulatory compliance

Continuous regulatory evidence, ready for inspection.

Reports generated automatically for audit. See how DROME addresses each regulation, requirement by requirement.

ANVISA · Brazil

ANVISA · RDC 430

Continuous monitoring with an immutable audit trail, automatic reports and excursion management for RDC 430, plus the medical gas installations covered by RDC 50 and NBR 12188.

View regulation → FDA · United States

FDA · 21 CFR Part 11

Electronic records, audit trails and IQ/OQ/PQ documentation to support your validation.

View regulation → European Union · EU GMP / GDP

EU GMP · Annex 11

Data integrity, audit trails and IQ/OQ/PQ documentation to support the validation of your system under Annex 11.

View regulation →

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