Every AccuraTrials feature that touches data integrity was designed around global regulatory standards — not retrofitted after the fact.
FDA electronic records and e-signatures rule. Every feature: credential re-auth on signature, immutable audit trail, automated Part 11 test harness on every build.
Good Clinical Practice standard for trial design, conduct, and reporting. Full subject traceability, SDV workflow, and protocol-adherent query management built in.
Protected Health Information safeguards. PHI fields are designated at the form level and access is controlled by role and site assignment. Audit trail covers all PHI access.
European data subject rights and privacy. Configurable retention policies, data access controls, and a full audit trail of every access event supporting data subject requests.
Every data modification is logged with timestamp, user, action, prior value, new value, and reason. Records cannot be altered after write. Full export for inspection readiness.
Automatic idle timeout enforces access controls without user action. Device fingerprinting, 28 granular permission bits, and à la carte per-user overrides.
AccuraTrials writes an immutable audit entry for every data change — who made it, when, from what value, to what value, and why. Nothing is editable after write.
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