CAPA

Improving your organization’s processes by eliminating causes of non-conformances

The FDA’s Corrective Action Preventive Action (CAPA) system requires that problems are investigated and prevented in future products. Including CAPA in a Quality Management System (QMS) is crucial for FDA compliance.

Planning and implementing CAPA requires time and resources. Many companies are either inexperienced with CAPA or lack adequate resources for implementation.

We assess clients’ current QMS systems and processes, make recommendations, and provide direction while helping to implement an effective CAPA process. As part of our CAPA Consulting services we can:

  • Perform and lead CAPA investigations
  • Determine client’s individual needs and where CAPA process can be of benefit
  • Evaluate the resources currently available for developing and implementing CAPA
  • Mentor and coach client teams to expedite CAPA implementation