Validation Excellence for CDMOs: From Regulatory Burden to Business Driver

The convergence of AI and Quality Management marks a paradigm shift in how Life Sciences organizations meet their GxP obligations. Examine key challenges—from compliance complexities and validation demands to talent shortages and risk management concerns.

As the life sciences landscape rapidly evolves, technology adoption demands agile validation methods to maintain GxP compliance. Learn how organizations can shift from project-based validation to a process-driven approach, integrating validation into their Quality Management System.

Manual computer software validation processes cost life sciences organizations up to 30% in additional project budget. As companies struggle to keep up with a surge of app and software integrations, they incur validation debt: the mounting cost of stretched resources, blanket testing, and missed GxP requirements.