CAPA Solutions

Corrective and Preventative Actions (CAPAs) provide essential improvements to your organization's processes.  They address and eliminate problems and other undersirable situations that have occurred or might occur.  CAPAs are one essential part of the GxP environment, and every person associated with the quality delivery of an organization's finished product must be cognizant of the implications of not meeting the requirements of regulators and customers who demand supreme quality.

The puzzle diagram represents a simplified process model of the FDA Quality System Regulations, 21 CFR Part 820. This is reproduced by permission of J. Jariwala, Compliance Officer, FDA CDRH (2013), who presented the diagram at the Sustaining Effective CAPA Systems Conference in July 2013, San Diego, CA.

 

The pages within the CAPA solution section of this web site are provided to educate readers about the elements and requirements around the provision of a CAPA system that is part of an overall quality management environment.  CAPA facilitates issue / signal management and provides clear evidence that quality is handled proactively, meeting the requirements of regulatory bodies in the USA, EU, and Asia. Each section also highlights the ways in which the ExtraView Enterprise product makes a difference. You may click on a jigsaw puzzle piece for more information, or use the navigation at the bottom of the page to find out more about the different CAPA phases.

CAPA Within a Quality Management Framework

CAPA is one of the most critical components of a comprehensive Quality Management system.  It is at the core of quality, hence its close scrutiny from regulatory bodies such as the FDA.  This diagram represents how CAPA fits within the framework:

CAPA Within a Quality Management Framework

The ExtraView Difference

The ExtraView Enterprise platform is an affordable, enterprise software solution that manages your CAPA process, automates workflow and provides on-going monitoring, while giving objective evidence of compliance and proactive management.

ExtraView Enterprise is fully customizable to meet your business needs and easily integrates with any existing quality, defect and complaint management systems.  ExtraView excels in providing you with a solution that follows your processes and your workflows, with simple tools to implement your requirements within a fully auditable, verifiable and validated environment.  Moreover, ExtraView includes a complete set of report types, all easily set up without the need for IT expertise.

Please click on a puzzle piece or a link below to learn more about how ExtraView Enterprise meets your business requirements in any particular CAPA area, or see the ExtraView CAPA Functionality Matrix for a quick synopsis.