Operational Readiness Frameworks For Pharma And Biotech: Identifying Risks Before They Surface

By Paige Kane, PhD, CPIP

Life sciences startups often view launch day as the finish line, but sustainable success requires viewing performance as a continuous journey. Moving effectively from "Day One" preparation into long-term stability demands a strategy that bridges the gap between Operational Readiness (OR) and Operational Excellence (OE). Rather than treating these as distinct phases with separate teams, integrating them creates a seamless transition where early risk assessments and governance structures naturally evolve into daily operating systems.

By establishing a continuum, organizations can leverage the momentum of startup to drive long-term efficiency across six key pillars, ranging from digital maturity and quality operations to organizational leadership. This integrated approach prevents the operational plateau often seen after mechanical completion, converting startup energy into a durable performance advantage. Read the full article to explore the six pillars of OE and practical steps for auditing your facility's maturity.