Streamlining Change Control For CDMOs

Approved product changes affecting multiple products and business functions necessitate seamless coordination among all involved parties to ensure the timely exchange of information. However, due to disparate processes and systems, communication between business functions primarily occurs through phone calls and emails, impeding cross-functional collaboration. Miscommunication between stakeholders can often lead to change execution without a comprehensive impact assessment, thereby resulting in downstream activities that lack justification for the benefit of the change.

A disjointed and inefficient change control process escalates compliance risks and delays decisions surrounding product shipment. Implementing a risk-based approach to change control allows for a more efficient process. Integrating disconnected systems and processes onto a modern cloud-based platform lays the groundwork for change control transformation. This white paper outlines a holistic approach for contract development and manufacturing organizations (CDMOs) to streamline the change control process, aiming to enhance quality, compliance, and time-to-market.