Smarteeva Audit Trail

Smarteeva Audit Trail: Effortless Tracking and Compliance

Smarteeva’s Audit Trail records every modification across every record type in the system. Color-coded visual cues make it immediately clear what was added, changed, or removed. Reviewers can see changes across the current record and all related records from a single screen, then formally acknowledge and verify modifications to create a compliance record.

Built natively on Salesforce, the audit trail inherits enterprise-grade security, role-based access controls, and field-level encryption. No bolt-on audit module. No separate system to maintain.

What You Will Learn

How color-coded change visualization works across complaint records, adverse events, investigations, and regulatory submissions. How unified record viewing consolidates all related changes into one screen. How configurable tracking lets you focus on meaningful data changes rather than noise. How the system supports FDA audit response, internal quality reviews, CAPA documentation, and training accountability.

Compliance Standards Met

21 CFR Part 11 electronic records and electronic signatures. EU MDR documentation and traceability requirements. SOC 2 Type II enterprise security and data handling standards. HIPAA eligibility for healthcare data. Full field-level encryption at rest and in transit.

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