Preparing Your ERP For Life Sciences Commercialization

By Jim Ingram

Approval is often treated as the finish line, yet it marks a shift to an entirely different operating model. Systems built for research and clinical trials were not designed for lot-level traceability, quality release controls, or true product costing, and many companies find that gap only when launch is close. This article looks at four foundational decisions that shape commercialization readiness, from when to move to a commercial ERP environment to how much validation a risk-based assessment actually calls for. It also considers why the question for emerging companies with outsourced manufacturing may be less about ERP size and more about visibility, integration, and control. Read on to see where your own readiness may stand.