The Ovada blog
Straight answers about AI in regulated quality
Plain-language answers to the questions quality leaders ask before putting an AI agent to work in an FDA-regulated operation.
Is Ovada quality management software?
Ovada provides the capabilities of quality management software through an AI quality agent that works across your existing QMS and approved systems.
October 6, 2026 · 3 min read02 / QMSDoes an AI quality agent replace your QMS?
An AI quality agent can perform authorized work across your existing QMS, but the QMS remains the approved system of record. Here is how the two fit.
October 6, 2026 · 2 min read03 / GovernanceCan AI make final quality decisions?
Can AI make final quality decisions? AI can gather evidence and prepare recommendations, but qualified people keep judgment, authorization, and accountability.
October 6, 2026 · 2 min read04 / ComparisonHow is an AI quality agent different from ChatGPT or Claude?
How an AI quality agent differs from ChatGPT or Claude: it adds approved procedures, evidence requirements, system access, controls, and human approval.
October 6, 2026 · 2 min read05 / WorkflowsWhat quality work can be automated with AI?
What quality work can be automated with AI? How to choose workflows using evidence requirements, approved rules, escalation paths, and qualified human review.
October 6, 2026 · 2 min read06 / MonitoringContinuous quality monitoring: what happens when AI finds a problem?
What happens when AI finds a quality problem: how an AI quality agent monitors approved sources, gathers evidence, and routes potential problems for review.
October 6, 2026 · 2 min read07 / 21 CFR Part 11How do electronic signatures and audit trails apply to AI quality workflows?
How electronic signatures, audit trails, validation, access controls, traceability, and human authorization apply to AI-enabled quality workflows.
October 6, 2026 · 2 min read