FDA 21 CFR compliance built in, not bolted on.
Electronic records, audit trails, and validation documentation automated.
DROME's architecture was designed from the ground up to meet 21 CFR Part 11 requirements. Every record is tamper-evident, every action is logged.
Cada artigo. Cada requisito.
Clique em cada regulamentação para ver como a DROME atende especificamente cada requisito.
21 CFR Part 11Electronic Records & Signatures
Requires that electronic records used to meet FDA requirements be trustworthy, reliable and equivalent to paper records.
Immutable audit trail with cryptographic signing, role-based access control, and FDA-compliant electronic signature workflows built into the platform.
21 CFR Part 211Current Good Manufacturing Practice (cGMP)
Establishes minimum requirements for methods, facilities, and controls used in manufacture, processing, packaging, and storage of drug products.
Automated calibration tracking, deviation management with CAPA workflows, and complete warehousing condition records with sub-minute granularity.
USP <1079>Good Storage and Distribution Practices
Provides guidance on proper storage conditions, temperature monitoring, and distribution of drug products to maintain their identity, strength, quality and purity.
Automated temperature mapping reports, continuous calibrated monitoring with configurable alarms, and documented excursion response workflows.
FDA GuidanceComputer Software Assurance
FDA's risk-based framework for software validation focusing on critical thinking and risk-based approaches rather than prescriptive documentation.
DROME ships with pre-written IQ/OQ/PQ documentation packages, reducing validation effort by up to 80% for FDA-regulated customers.
Pronto para simplificar seu compliance?
DROME's architecture was designed from the ground up to meet 21 CFR Part 11 requirements. Every record is tamper-evident, every action is logged.
Schedule a 21 CFR 11 compliance review