Audit, Compliance & CAPA Community of Practice

The purpose of this MCC Community of Practice is to explore leading practices with Audit, Compliance & CAPA in clinical trials. We discuss how we can improve quality, reduce cycle times, and make better use of available data on issues that matter. MCC Communities of Practice are about members helping members. MCC hosts these online meetings and associated LinkedIn Groups for members to learn from each other by sharing case studies, discussing challenges and developing possible solutions.

Team Output:

  • We are building a library of recorded Subject Matter Expert webinars on relevant topics
  • Existing Metric Toolkits include the

MCC CAPA Process Metrics Toolkit v1.0

Component Purpose
Metric Toolkit Overview (Recorded Webinar) To provide an overview of purpose of the metrics and how to use the toolkit.
Process Map with Metrics To show the location of the MCC metrics in relation to the high level process
Metrics Workbook To define each metric. Includes purpose, recommended usage, target, glossary and process map

 

MCC member organizations can download the MCC CAPA Process Metrics Toolkit v1.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.

Team is Exploring:

Topics suggested by Community of Practice members. For example:

  • Effective Root Cause Analysis
  • Categorization of issues / findings and trending
  • Effectiveness Checks – theory and practice
  • CAPA process and measurement
  • Linking RBQM and CAPA

MCC Membership Information

This is a member-only group. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland or call 317-622-0266. Return to Work Group List

Metric Info Sheet DOWNLOAD

MCC CAPA Process Metrics Toolkit v1.0

  • Metric Toolkit Overview
  • Process Map with Metrics
  • Metrics Workbook

Additional Resources

MCC follows the metric development process. For more information about the process:

MCC’s Metric Development Framework: Defining Metrics That Answer Key Performance Questions View white paper, Listen to podcast

Unlock the Value of MCC Metric Sets: Use MCC Metric Selection Tools to Select the Right Metrics for Your Organization View white paper, Listen to podcast

Additional white papers available here.

Contact MCC Membership Director Teresa Holland to learn how your organization can access the entire library of metric toolkits in the MCC Knowledge Portal!

Join Our LinkedIn Community

Employees of MCC member organizations are invited to join the MCC Audit & Compliance LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.