Infrastructure & Hosting
Enterprise security with encrypted data, isolated environments, flexible deployment, continuous testing, and proactive threat management.
Authentication & Access
Enterprise identity management with SSO, MFA, granular role-based access, automated provisioning, and comprehensive audit logs.
Audit Trail & Data Integrity
Tamper-evident audit trails, cryptographic evidence verification, ALCOA+ compliance, and exportable audit records ensure complete traceability.
Part 11 / Annex 11 Responsibility Matrix
Eventt AI provides
Your organization manages
Attributable electronic signatures binding identity, meaning, action, and timestamp, with re-authentication at point of signing
Defining who is authorized to sign, and the meaning of each signature, in your SOPs
An append-only, hash-chained audit trail emitted through a single enforced code path
Reviewing the audit trail and retaining records under your retention policy
Role-based access control with six fixed roles and a hard read-only Auditor role
Assigning users to roles and performing periodic access reviews
SSO-only authentication (Okta, Entra ID, Google OIDC, SAML 2.0), enforced MFA, and SCIM provisioning
Operating your identity provider and setting your provisioning and MFA policy
Hash-anchored, ALCOA+ evidence capture, verified against its SHA-256 hash on retrieval
Determining whether the captured evidence is sufficient for your intended use
Validation package assembly with review, approval, and Part 11 e-signature workflows
The compliance determination and the release decision
A vendor-assurance package: intended use, release notes, testing evidence, traceability, and change notifications
Your own validation of the platform, including IQ/OQ/PQ acceptance
Exportable records in DOCX, PDF, CSV, and JSON
Archival and long-term record keeping in your own systems
Encryption at rest and in transit, per-tenant isolation, and separation of sandbox and production
Your data classification and internal access governance
Risk-based test generation with source citations and confidence scores, and fail-closed execution
Approving requirements, test scripts, and results, which remain review-gated
Comprehensive vendor assurance with validation documentation, traceability, controlled SDLC, AI governance, and a transparent sub-processor registry. Customer data is never used to train shared or third-party models.
Get started
Audit Trail
ISO 27001
Independently examined controls for security and availability. Report available for review under NDA.
Certified information security management system covering the platform and its operations.
A Business Associate Agreement is available for customers who process protected health information.
Supported with a Data Processing Agreement (DPA), a sub-processor registry, and a Data Protection Impact Assessment (DPIA).
The platform provides the technical controls to support these regulations; the compliance determination remains with your quality organization.
Eventt AI is a GAMP 5 Category 4 configured product, with risk-based generation and execution that scales evidence to intended use.
