How Ovada Works

AI Compliance Software Built for Controlled Quality Work

Ovada combines deterministic checks, bounded AI, regulatory context, and human review to automate regulated Quality work with traceable evidence and controlled outcomes.

See Ovada in Action Explore Quality Workflows
  • Deterministic checks
  • Bounded AI
  • Human review gates
  • Auditable evidence

Agent · supplier change assessment

SUP-2026-0142
Controlled quality record

Supplier change notice · excipient grade

Awaiting QA

Completeness checkRule · all required fields present

Pass

Specification limitsRule · within approved specification

Pass

Impact assessmentAI · drafted · cited to notice §2

Ready

Supplier qualificationRule · requalification due in 12 days

Flagged

DispositionHuman · qualified signature required

Awaiting
Human approves
Audit trail · append-only

10:31:04 notice.received · SUP-2026-0142

10:31:07 checks.completed · 4 rules

10:31:12 impact.drafted · cited

01 / How Ovada Works

General-Purpose AI Starts With a Prompt. Ovada Starts With a Workflow.

General-purpose AI responds to instructions. Ovada follows a defined quality process from the start.

The Process Is Predefined

Each workflow has defined triggers, steps, checks, obligations, review gates, and expected outputs.

AI Does Not Decide the Workflow

AI works inside the process. It does not choose which steps to follow or invent the workflow as it goes.

Quality Keeps the Final Decision

Human review and sign-off remain in place whenever the process calls for qualified judgment.

02 / How Ovada Works

How Ovada Works

Ovada moves regulated quality work through a controlled sequence from trigger to decision.

  1. 01

    A Quality Event Triggers the Workflow

    A deviation, supplier change, SOP revision, OOS result, CAPA, COA, regulatory update, or release event can start the process.

  2. 02

    Ovada Resolves What Applies

    The workflow identifies the relevant requirements, records, specifications, procedures, and obligations for the case.

  3. 03

    Deterministic Checks Run

    Rules handle repeatable checks such as completeness, specification limits, qualification status, blockers, routing, and trigger logic.

  4. 04

    AI Handles Bounded Work

    AI supports focused tasks such as document parsing, interpretation, drafting findings, and summarizing evidence.

  5. 05

    Quality Reviews the Evidence

    Missing evidence or decisions that require judgment are routed to the right reviewer instead of being filled in automatically.

  6. 06

    The Decision Is Recorded

    The authorized reviewer makes the decision, with the supporting evidence and signature retained where required.

03 / How Ovada Works

Deterministic Where It Should Be. AI Where It Adds Value.

Ovada uses rules for consistency, AI for interpretation, and people for accountable decisions.

Deterministic Checks

Use rules when the same facts should produce the same operational result.

  • Is required information missing?
  • Does the result meet specification?
  • Is supplier qualification current?
  • Is an investigation still open?
  • Should another workflow be triggered?

Bounded AI

Use AI where interpretation or drafting adds value.

  • Parse a supplier notice
  • Assess procedure language
  • Draft an impact assessment
  • Summarize structured findings

Human Judgment

Use qualified people where accountability belongs with Quality.

  • Approve or reject
  • Release or hold
  • Accept a root cause
  • Close a CAPA

Agent · incoming material · lot MG-26-0412

COA-2026-0671
CheckHandled byResultStatus
Required fields presentRuleCompletePass
Assay vs. specificationRule96.1% vs ≥ 98.0%Fail
Impact assessmentAIDrafted · citedReady
Material dispositionHumanSignature requiredAwaiting
Division of work

Rules handled the repeatable checks. AI drafted the interpretation. A qualified person makes the disposition.

04 / How Ovada Works

From AI Output to Auditable Evidence

Ovada turns workflow results into something Quality can actually review and act on.

Recommendation

Ovada presents the proposed action or disposition for review.

Supporting Evidence

The reviewer sees the records and information behind the recommendation.

Items Requiring Attention

Ovada surfaces blockers, missing evidence, and issues that need human judgment.

Available Actions

Reviewers get defined actions such as approve, reject, hold, escalate, or return for more information.

Review and Signature

The authorized person reviews and signs the record where required.

05 / How Ovada Works

Why Not Just Use General AI?

General AI can help with individual tasks. Ovada is built around the full quality process.

General AI

  • The prompt defines the task
  • The approach can vary
  • The output is open-ended
  • The user determines regulatory context and next steps

Ovada

  • The workflow defines the process
  • Required checks are predefined
  • Regulatory obligations are tied to the workflow
  • Evidence requirements are structured
  • Human review gates are built in
  • Findings can trigger downstream quality workflows

06 / How Ovada Works

One Architecture Across Quality Operations

Ovada applies the same controlled approach across different Quality processes.

Gap Assessment

Establish where the quality system stands against the applicable requirements.

Quality Workflows

Execute the work created by findings, events, and day-to-day Quality operations.

  • Supplier & Material Quality
  • Deviations, CAPA & Change Control
  • Batch & Release
  • Quality System Operations
Explore Quality Workflows

07 / How Ovada Works

AI Built Around the Quality Unit

Ovada automates more of the operational work before a regulated decision, while keeping the evidence visible and the final decision with the appropriate person.

See Ovada in Action
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