CAPA MANAGEMENT

Vivaldi Corrective and Preventive Action (CAPA) management helps you to continually improve the effectiveness of your quality management system.

Our CAPA solution leads you to compliance with ISO standards such as ISO 9001, ISO 13485, ISO 17025 and FDA.

Download Brochure Schedule Demo

Start and link CAPA’s from within any other Vivaldi process.

A CAPA can be initiated as an independent registration or can be launched directly from another process like a customer complaint, an internal audit or a deviation. Links are maintained so users can overview the whole process and can see what triggered the CAPA.

Plan

Identify, analyze and track all possible root causes. 

Execute detailed risk assessments. Determine what actions need to be taken.

Do

Implement and document the result of the CAPA.

Register all relevant data in the customizable CAPA form, attach implementation reports or pictures.

Check & Act

Measure and validate the effectiveness of the CAPA.

If the effectiveness is below satisfaction, the loopback mechanism in the CAPA process will allow you to respond and take action.

Monitor your CAPA data through your dashboards.

The dashboards are easy and smooth to navigate throughout the information and can be customized to present the most valuable and useful data. This allows each group of users to see the overview lists, Pareto graphs and Trend analyses they need in order to get their job done and meet their goals.

Contact us
  • Dashboards
  • Flexible ready-to-use workflow processes
  • Easy Form Design
  • Audit Trail
  • Mobile: works on any device
  • Connectivity & Integration (API)
  • Electronic Signature (21 CFR Part 11)
  • Available in the cloud or On-Premise