Case Study

Streamlining Change Control to Increase Efficiency and Compliance for CDMOs

Streamlining Change Control to Increase Efficiency and Compliance for CDMOs

Pages 5 Pages

veeva.com 1 STREAMLINING CHANGE CONTROL TO INCREASE EFFICIENCY AND COMPLIANCE FOR CDMOS Streamlining Change Control to Increase Efficiency and Compliance for CDMOs Drive continuous quality improvement by connecting people, processes, and technology Today’s Reality: The Broken Change Control Process Approved product changes impacting multiple products and business functions require all parties to coordinate to record and exchange information on time. However, because of separate processes and systems, business functions communicate via phone calls and emails, making cross-functional collaboration difficult. Miscommunication among stakeholders often leads to change execution without full impact assessment, resulting in downstream activities that are not justified by the benefit of the

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