Quality Management System Design, Gap Analysis, Implementation, and Improvement
Gain Peace of Mind. Remove the Guesswork. Fill the Resource Gap.
Avoca’s Consulting Services for the design, development, and implementation of a Quality Management System (QMS) aims to help sponsors and CROs develop a culture of risk prevention rather than one of managing issues.
A proactive, risk-based approach ensures patient safety, improves data quality, provides data integrity, and increases inspection preparedness.
Why is a Quality Management System Important?
To be compliant with ICH E6 (R2), risk-based quality management for clinical trials is required. A QMS is a framework for all activities, including quality control, quality assurance, quality improvement, and the reporting of these activities within an organization.
Learn how quality management system components affect inspection readiness – watch our webinar.
The Avoca Advantage
Consulting
Gain Peace of Mind
Over the past 20 years, Avoca has built a proven process to help sponsors and CROs drive efficiency in clinical trial execution. We developed a 12-component construct to facilitate comprehensive, robust gap assessments of existing QMS.
![](https://www.theavocagroup.com/wp-content/uploads/2022/07/img_12-Components.png)
Remove the Guesswork
Using our construct, we help to ensure your QMS is compliant with current regulatory requirements (e.g., ICH E6 (R2)) and leading industry practices and standards.
![](https://www.theavocagroup.com/wp-content/uploads/2022/07/img_Readiness-to-Preparedness.png)
Tools
Fill the Resource Gap
We alleviate time, staff, and other resource constraints that prevent compliance and preparedness assurance — allowing your team to focus on their core responsibilities. To simplify and streamline the successful implementation of your company’s QMS, we leverage the 1,000+ quality management and inspection readiness leading practices, tools, standards, and metrics developed and refined by the Avoca Quality Consortium (AQC).
Leverage Our QMS Consulting Service
![](https://www.theavocagroup.com/wp-content/uploads/2022/07/img_the-gaps-v6-1024x237.png)
- Collaboratively work with stakeholders to develop the project charter and define the roles and responsibilities.
- Interview key stakeholders to assess the current state and define the desired state.
- Review relevant SOPs or procedures and associated tools and work instructions.
- Identify gaps related to external regulations and leading practice.
- Provide a gap assessment report and implementation roadmap to close the gaps.
- Provide leading practices, tools, and templates to build a fit-for-purpose toolkit.
- Based on the identified gaps and implementation roadmap, Avoca experts assist with:
- Development of:
- Customized training materials.
- Metrics.
- Staffing requirements.
- The strategy and setting the stage for change management, including execution of the communication plan across the organization.
- Revisions to SOPs and/or work instructions.
- Training sessions.
- Conduct of mock audits.