Built for the validated environment.
How Ovada AI fits into your QA team's existing controls and validation surface.
Validation
Designed to fit the validation work your QA team already does
Three principles guide the product: risk-based scoping, transparent outputs, and human checkpoints on consequential decisions.
Risk-based scoping
We align with GAMP 5 categorization. The functions Ovada performs — document parsing, specification comparison, workflow orchestration — are evaluated at appropriate rigor levels rather than as a single monolithic system. Validation effort stays proportional to actual risk.
Transparent outputs
Every flag, comparison, and dispositioning recommendation Ovada produces links back to the source document and the specific evidence the agent used. Your reviewers can verify any output against the underlying evidence in seconds — the foundation of validatable AI use.
Human checkpoints
Consequential decisions — lot release, vendor approval, material qualification — always require human approval through dedicated review interfaces. The agent does the legwork; people make the calls. This keeps the validation surface manageable: you're validating that Ovada presents information accurately and routes work correctly, not that it makes regulated decisions on its own.
Customer validation support
We provide documentation packages including system descriptions, data flow diagrams, and example test scripts that customers can use as starting points for their own URS, IQ, OQ, and PQ work. Our change control process notifies customers in advance of any change that materially affects validated functionality.
21 CFR Part 11 Alignment
Records, signatures, and access controls aligned with Part 11
Audit trail
Every action in Ovada — by users or by agents — is captured in an immutable, time-stamped audit trail with full attribution. Records cannot be modified or deleted after the fact, only superseded.
Access controls
Role-based access control (RBAC), authentication via SSO (SAML / OIDC), and session management aligned with regulated environments. All access is logged.
Electronic records
Records are stored with integrity controls, retention configured per customer policy, and exportable in standard formats for regulatory submission or inspection response.
Electronic signatures
Where customer workflows require e-signatures, Ovada captures the required authentication, intent, and meaning consistent with Part 11 requirements.
Architecture & Data Handling
Multi-tenant by default. Single-tenant for enterprise.
Ovada operates a multi-tenant cloud architecture with logical separation between customers. Enterprise customers operate in a single-tenant cloud architecture. Customer data is encrypted in transit (TLS 1.2+) and at rest (AES-256). Access to production systems is restricted to authorized personnel under role-based access controls, with all access logged and reviewed.
Documents and metadata processed by Ovada are retained for the duration of the customer relationship per agreed retention policy, and exportable on request. Specific data-handling commitments — including data residency, retention beyond contract term, and data use — are documented in the customer agreement.
Talk to us about your validation requirements.
We'll walk through how Ovada AI fits into your QA team's controls and validation surface.