Capitalizing on Regulatory Change for Optimizing Quality-System Effectiveness: A Case Study on the Practical Implementation of a New Global Quality Process

Paul Hastwell, Tegan Francis, Jane Winter

Quality Change Methodology Guiding Principles

• Coordination of initiatives across the organization to minimize disruption

• Integrated planning around future landscape to minimize effort

Can I capitalize on regulatory changes to drive innovation in the organization?

• Proactive assessment of industry/business issues

• Formulate creative solutions

• Align industry trends to business strategy

• Cross-functional approach to scenario planning and solutions building

Innovative Solutions

• Assimilation of change topics into single initiative

How do you manage regulatory change for effective adoption?

• Implement changes into current processes

• Maintain quality requirements

• Subject-matter expertise drawn upon to create innovative solutions

• Governance Committee includes active participants across business functions

Case Study: Risk-Based Strategy to Support Confidence in QMS Case Study: Development of a SOP Framework Case Study: Implementation of a Global Serious Breach Process

Value Outcome: Providing an external perspective with hands-on experience to ask the right questions

Situation Prompted by site audit findings, our client wanted to develop a future state “risk-based” strategy to improve quality, effectiveness, and performance of site audits

Action

• Through conducting a series of discovery workshops, surveys, and interviews with cross-functional stakeholders, we sought to answer the following key questions:

1. What does a risk-based, site-audit strategy need to encompass?

2. How do measure being in control?

Results

• Defined strategy for proactive risk-impact assessments, risk plans, risk-assessment methods, issue escalation, and ownership of risks/issues

Value Outcome: Increased speed of change adoption

Global organization with little consistency in QA system wanted to simplify and optimize the current SOPs for clinical operations

• After “current-state” process was mapped, we brought the project team together prior to beginning “future-state” definition to consider the key requirements for the SOP update

• Developed framework for SOP updates that enables successful adoption of the change through effective change management, training, and communications

Value Outcome: Reduced change burden for EU Clinical Trial Regulation readiness

Serious Breach notification to be extended from the UK to EU under Regulation (EU) 536/2014

• New process design, including a new “Serious Breach Assessment Committee,” bringing together people from Quality, Study Management, Regulatory, Drug Safety, and Medical functions

• Designed new roles and IT system to support the new process

• Implementation planning for the new process across all stakeholders

• Cross-functional steering committee

• Global enterprise stakeholder collaboration and adoption

• Increased compliance now and ready for future