Improving quality and compliance in the life science industry

CAPA System

The FDA reports that a leading cause of observations and warning letter issuance is deficiency within the CAPA system. Many organizations struggle with CAPA, unable to differentiate ongoing procedures from the entire system.

CAPA is not a procedure — it is a system of very different yet interrelated activities. PathWise offers a complete CAPA System, providing all of the tools necessary to build and maintain a compliant, effective and efficient CAPA system.

System Elements

The PathWise CAPA System contains the following six key elements:

CAPA Management Controls
  • System Management
    The requirements to manage the CAPA System as a business process.
  • System Review
    The process of analyzing the CAPA System Metrics and escalation to Management Review.
  • Projects Review
    The requirements for review and management of CAPA projects.
  • Trending
    The requirements to analyze and trend nonconformance quality data and CAPA effectiveness.
Escalation Process CAPA Process
A risk-based process for analyzing the severity of an issue, documenting the outcome, and linking quality processes utilizing a common escalation process:
  • Nonconformance
  • CAPA Request
  • Trending
The requirements to execute and document the six phases of a CAPA project:
  1. Initiation
  2. Investigation
  3. Action Plan
  4. Implementation
  5. Effectiveness Check
  6. Closure

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FDA, CAPA & Regulatory Compliance Training

Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.

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