Interlocking SIPOCs
Interlocking SIPOCs: Bringing Lean Strategies into the Digital Age
Transcelerate
Quality by Design for Clinical
less than a minute
The foundational paper that set the groundwork for implementing a quality management system (QMS) through which organizations can systematically plan and achieve their quality objectives. Paper addresses both the culture and system components that are required to achieve.
Components of the framework helps organization compartmentalize and deliver on the final vision and strategy. Key components within which we are foundational include:
- Understanding the context (Internal & External environments)
- Leadership Commitment to Quality (e.g., proactive risk mitigation)
- Organizational Commitment (e.g., ownership by everyone)
- Continuous Improvement (e.g., never satisfied with status quo)
https://journals.sagepub.com/doi/pdf/10.1177/2168479015596018
Knowledge Management
A Knowledge Management Framework and Approach for Clinical Development
Risk Framework
Quality Risk Management Framework: Guidance for Successful Implementation of Risk in Clinical Development
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