The ANVISA 38/2020 compliance extension in Log360 is designed to help your organization maintain a validated state. By automating audit trails, monitoring access to sensitive data, and providing real-time visibility into system changes, Log360 ensures your security operations align with ANVISA’s data integrity standards without slowing down your digital transformation.
Here are some extension's capabilities:
Comprehensive Audit Trails for Data Integrity Maintain a complete, tamper-proof record of "who, what, when, and where" for every interaction with your electronic records. Log360 tracks all modifications, deletions, and access attempts, ensuring the authenticity and traceability required by ANVISA inspectors.
Proactive Threat and Anomaly Detection Leverage ML-powered UEBA to detect anomalous behavior that could signal a breach or an internal threat to data integrity. Receive instant alerts for critical events such as mass file deletions, unauthorized privilege escalations, or unusual login times.
Audit-Ready ANVISA Compliance Reports Generate preconfigured reports specifically mapped to the technical requirements of RDC 38/2020. These reports provide the necessary evidence for regulatory inspections, demonstrating that your electronic systems are secure, monitored, and under control.
The Resolução da Diretoria Colegiada (RDC) nº 38/2020 is a critical regulation for the Brazilian life sciences sector. It focuses on the reliability and security of electronic data and documents submitted to ANVISA. The regulation emphasizes the need for robust cybersecurity measures, including electronic signatures, rigorous access controls, and detailed audit trails to prevent data falsification or loss.
Entities within the scope of RDC 38/2020 must prove that their computer systems are validated and that all electronic actions are attributable to a specific individual. Failure to comply can lead to delays in product registrations, heavy fines, and significant reputational damage in one of the world's most regulated healthcare markets.
Have questions about Log360’s extension capabilities or need technical guidance?
