The mission of CQS is to drive synergy across diverse quality functions to develop strategy, anticipate and mitigate quality risks, leverage knowledge across the enterprise and drive quality excellence to achieve product realization and accelerate access to innovative therapies for our patients.
This program was built by exploring existing frameworks for asset support, developing a cross functional quality business model, training and developing resources, testing the model through a pilot program, collecting feedback, and continuing to evolve the program.
Overall, the assessments and feedback received at this stage of the program indicate that CQS teams do enhance quality asset support. Key findings:
- Established a fit-for-purpose business model that demonstrated the benefits of cross functional collaboration, leading to greater alignment and awareness of overall activities, risks, and proactive action as it relates to the asset.
- With QRM as its foundation, identified classification of risks requiring additional CQS resourcing
- Identified data sources and established tools to support the process and quickly view asset quality health indicators
- Increased awareness of quality risks and collaborated cross-functionally to execute appropriate mitigations
- Process is scalable across the drug development lifecycle, but highest need appears to be in Phases 2-3.
- Highest value is found where there is greater complexity (i.e high priority, acceleration, complex supply chain, new regulations, acquisition/collaboration, product complexity, unclear support matrix, etc.)
By extracting diverse quality functional knowledge and combining it, we create an environment of cross pollination and idea generation that strengthens strategy development and proactive quality support. Further evolution of the program and process is needed to capitalize on the foundation that has been built. Next steps will concentrate on:
- Selection of CQS assets, bringing in assets that will benefit the most from a CQS team.
- Streamlining teams and activities
- Growing the program to reach more assets
- Building CQS relationships and connectivity beyond quality
- Developing cross-functional quality asset support models to provide more guidance on quality focus as assets move through phase gates
- Develop knowledge management and lessons learned guidance and tools