Why Manual QbD Leads To Delays, Errors, And Ongoing Frustrations

By Ryan Chen, Product Strategist, ValGenesis

Chemistry, Manufacturing, and Controls (CMC) is often seen as a technical checkpoint in drug development—but it’s far more than that. CMC teams are responsible for ensuring consistent quality and compliance across a complex ecosystem of formulation, analytics, manufacturing, and regulatory strategy. Yet many still rely on manual Quality by Design (QbD) processes that introduce delays, errors, and inefficiencies. This article explores how digital, AI-enhanced QbD frameworks are transforming CMC by streamlining workflows, improving traceability, and accelerating decision-making. It also highlights the hidden costs of manual methods—from lost context to team burnout—and makes a compelling case for why intelligent QbD isn’t just a modernization effort, but a strategic advantage.

If your organization is still managing QbD through spreadsheets and emails, it may be time to rethink your approach.