Today’s contract development and manufacturing organizations (CDMOs) face unprecedented pressure from multiple fronts: evolving client demands, shifting regulatory landscapes and intense global competition. As manufacturing contracts grow increasingly complex, traditional validation approaches are becoming unsustainable burdens on resources and timelines, creating bottlenecks that slow operations and increase audit risk exposure.
The life sciences industry stands at a critical juncture in system validation. As organizations navigate an unprecedented wave of technological change—characterized by cloud-based systems, frequent updates and extensive integration—traditional project-based validation methods are revealing significant limitations. These outdated approaches not only create operational bottlenecks but also accumulate “validation debt”: the compounding cost of unaddressed burdens and future liabilities that threaten both compliance and innovation.
In this webinar, industry experts will explore how CDMOs can transform validation from a burden into a business differentiator. They will examine the shift from computer system validation (CSV) to computer system assurance (CSA), a risk-based paradigm that increases efficiency by replacing end-to-end “blanket” testing with risk-prioritized approaches.
