Connecting and leveraging data product lifecycle
Advancing Beyond CAPA Compliance, Using Innovation for Improvement and Growth - Part 1
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.
Advancing Beyond CAPA Using Innovation for Growth and Improvement
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.
How to Kick-Start Your CAPA Process
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.
Does Your CAPA Need a CAPA?
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.
How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
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.
Clinical CAPA: Embedding Quality into Clinical Research
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).
Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment
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.
Simplifying CAPA: Seven Steps
A comprehensive CAPA process consists of seven key actions that should be tracked and documented.
9 Free Resources to Boost Your CAPA Management System
A CAPA program embodies the practices and processes that both FDA inspectors and ISO auditors consider singularly critical.
The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?
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.
MasterControl Field-Based Solutions (FBS) CAPA™
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.
MasterControl Supplier Corrective Action (SCAR)™
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.
Demo: MasterControl Customer Complaints/CAPA Management Software
MasterControl complaint software streamlines the customer complaint process for improved safety and compliance.
Quality Event Management and the CAPA System Part 2: Taking Effective Actions
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.
Demo: MasterControl Clinical CAPA
MasterControl Clinical Excellence™ offers a comprehensive clinical quality management system (CQMS) that handles every component of clinical trials, including CAPA management.
Demo: MasterControl CAPA Software
Corrective and preventive action (CAPA) is difficult to manage unless you have CAPA software that connects all your quality processes. As part of the MasterControl QMS, MasterControl CAPA lets you lau