Happy World Quality Week! Together with organizations around the world, we are celebrating this year’s theme, “Quality: from compliance to performance.” World Quality Week provides a chance to reflect on the role of quality and the importance of developing innovative and sustainable strategies to navigate complexity and face challenges in today’s dynamic landscape.

WCG’s Avoca Quality Consortium (AQC) brings together key stakeholders to enable industry collaboration and move the industry forward by elevating clinical trial quality, maintaining regulatory compliance, improving efficiency, and mitigating risk. Members have access to 1,500+ tools, templates, metrics, and more in the AQC Knowledge Center. They connect, learn, and stay current on industry topics through 50+ meetings annually. We acknowledge and celebrate the 200+ member organizations of the AQC for focusing on quality principles that drive beyond compliance to outstanding performance.

World Quality Week explores practical strategies and insights to help organizations harness the power of quality, which align to AQC resources and initiatives:

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Take action with AQC resources focused on quality and compliance to navigate the complexities of clinical trials, together.

Contact us today to get involved in the AQC! ›

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The post The AQC Celebrates World Quality Week 2024: November 11-15 appeared first on Avoca, a WCG company.

With the upcoming AQC member resources, you will:

• Get inspection-ready from the start with mapping of AQC tools for each phase of the clinical trial lifecycle and see what is needed to kickstart your study.
• Build your quality management system (QMS) and streamline processes with mapping of AQC tools to the QMS.
• Gain access to a provider qualification (PQUAL) and oversight resource page, with a new leading practice for third-party subcontracted vendor qualification and oversight.
• Mitigate risk with a new Quality by Design/Risk-Based Quality Management (QbD/RBQM) overview with supporting resources and a new leading practice for risk-based approach for audits.
• Utilize new leading practices for effective issue management, including escalation pathways, issue log template, root cause analysis, and effectiveness checks.
• Focus on site quality with guidance on site qualification/oversight of decentralized clinical trial (DCT) providers, protocol evaluation, and electronic investigator site file (eISF) adoption.
• Elevate inspection readiness, boost innovation adoption, leverage AQC University courses, and plan for ICH E6 (R3) readiness and implementation.

AQC members can head over to the Knowledge Center to access the library of 1,500+ tools, templates, guidelines, metrics, and more to support and improve clinical trial processes. Stay tuned as great new additions are released.

Contact us today to get involved! ›

// ABOUT THE AQC //

The post AQC Member Resources: There’s Still More for 2024! appeared first on Avoca, a WCG company.

We are pleased to announce the launch of WCG’s Avoca Quality Consortium (AQC) medical device workstream!

Medical device guidance and regulations require manufacturers, or sponsors of device manufacturing, to adhere to rigorous processes to obtain regulatory approval and to maintain the safety and efficacy of products. This new AQC workstream enables collaboration and action needed to advance your clinical research, saving valuable time and resources with expert-developed tools, templates, and guidance.

The first set of leading practices is specific to design controls, which are essential to help ensure that products are safe, effective, and meet regulatory standards before they reach the market.

• Design Control Overview and Requirements
• Design and Development Plan and Template
• User Needs Document and Template
• Design Input Requirements and Traceability Matrix Template
• Design Output Requirements
• Design Verification and Validation
• Design Transfer Requirements and Template
• Design Reviews and Template
• Design History File and Template

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The AQC’s leading practices for the design and development of medical devices, or combination products that have a device constituent, help to navigate specific medical device regulations, including those from the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Leading practices on risk management and management responsibilities are coming soon.

AQC members can view the new Medical Device Workstream page in the Knowledge Center for more information and links to resources.

Join the AQC now to leverage these critical documents and to be instrumental in shaping the future of the medical device library and workstream!

CONTACT US TO JOIN ››

// ABOUT THE AQC //

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