Risk-based scoping
Ovada aligns with GAMP 5 categorization. Document parsing, specification comparison, and workflow orchestration are evaluated at appropriate rigor levels rather than as one monolithic system.
Security & validation
Built for the validated environment.
How Ovada fits into your QA team's existing controls and validation surface.
01 / 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.
Transparent outputs
Every flag, comparison, and dispositioning recommendation links to the source document and the specific evidence used. Reviewers can verify any output against its evidence in seconds.
Qualified human checkpoints
Lot release, vendor approval, and material qualification always require human approval through dedicated review interfaces. The agent does the legwork; people make the calls.
Customer validation support
Documentation packages include system descriptions, data-flow diagrams, and example test scripts that customers can use as starting points for URS, IQ, OQ, and PQ work.
02 / 21 CFR Part 11 alignment
Records, signatures, and access controls aligned with Part 11.
Audit trail
Every user and agent action is captured in an immutable, time-stamped audit trail with full attribution. Records can only be superseded.
Access controls
Role-based access control, SSO through SAML or OIDC, and session management align with regulated environments. All access is logged.
Electronic records
Records are stored with integrity controls, retained according to customer policy, and exportable in standard formats for regulatory submission or inspection response.
Electronic signatures
Where workflows require electronic signatures, Ovada captures the required authentication, intent, and meaning consistent with Part 11 requirements.
03 / 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 with TLS 1.2+ and at rest with 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 are retained for the duration of the customer relationship according to the agreed retention policy and are exportable on request. Data residency, retention beyond the contract term, and data-use commitments are documented in the customer agreement.
Security & validation
Talk to us about your validation requirements.
We'll walk through how Ovada fits into your QA team's controls and validation surface.
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