In this two-part series, MasterControl Partner Ken Peterson uses his corrective and preventive action (CAPA) expertise to bring creativity and improvement into your business processes.
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.
In a regulated environment, a corrective and preventive action (CAPA) process is the cornerstone of a company's compliance efforts and essential to ensuring product quality and safety.
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 comprehensive CAPA process consists of seven key actions that should be tracked and documented.
A CAPA program embodies the practices and processes that both FDA inspectors and ISO auditors consider singularly critical.
In this Q&A with MasterControl, QMS and CAPA expert Ken Peterson covers a number of issues in the development and implementation of a state-of-the-art QMS CAPA system.
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.
Corrective and preventive action (CAPA) is the single-most critical element of any quality system, and must be managed as such to satisfy both FDA and ISO requirements.
Flier describes MasterControl's CAPA solution, outlining the features and benefits for users at different levels of an organization.
MasterControl complaint software streamlines the customer complaint process for improved safety and compliance.
In part two of the series, MasterControl Partner Ken Peterson talks about identifying the root cause of a CAPA and determining which action completely eliminates that cause.
MasterControl Clinical Excellence™ offers a comprehensive clinical quality management system (CQMS) that handles every component of clinical trials, including CAPA management.