CAPA Signs

Creating solutions when traditional problem solving and investigations may not work—or when an improvement or breakthrough is needed beyond a traditional CAPA approach—may be more art than science.

This white paper presents a six-step process to improved CAPA investigation along with a four-phase CAPA implementation plan to help kick-start CAPA in your organization.

Given the enormous cost, time, and effort involved in clinical research, sponsors and CROs need to mitigate risks and ensure compliance during development to be able to launch their products.

Managing quality in a clinical trial must begin long before the first patient is enrolled and continue through the completion of the clinical study report (CSR).

Over the last couple of years, we have seen a significant increase in warning letters and consent decrees that have in some cases caused a supply chain delay or even plant closure.

A CAPA program embodies the practices and processes that both FDA inspectors and ISO auditors consider singularly critical.

An easy-to-use solution for automating the CAPA process and integrating it with other quality processes for a holistic, connected and compliant approach to quality management.

Effectively extend the core of a continuous quality improvement system—CAPA—to suppliers. Broaden supply chain integration beyond purchasing in order to achieve truly comprehensive quality management.