Compliance & CAPA Community of Practice

Come and Join Us!

The MCC Compliance & CAPA Community of Practice will launch with an online meeting 10-March-2020 at 11 am EDT.

REGISTER NOW Open to the Public

This Work Group focuses on the MCC metrics sets for CAPA, Compliance Quality, Site Quality Management, and Vendor Oversight Quality. The metrics from these sets can be used in different parts of the clinical trial process but are all focused on quality, CAPA and compliance. They help organizations measure and monitor these processes which can contribute to overall improved quality.

Team Output:

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:

  • Current approaches to measuring and managing Clinical CAPA processes
  • How process maps help to define and visualize the CAPA process
  • How the wrong combination of performance metrics can undermine the CAPA management process
  • Establishing a set of standardized MCC CAPA performance metrics
  • The feasibility of defining a common Issue Categorization Framework that can be used across issue detection and management programs

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

Interested in discussing Compliance & CAPA with your peers? Take the survey!


Join Our LinkedIn Community

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