CAPA Management

  • Connecting and leveraging data product lifecycle

    Connecting and leveraging data product lifecycle

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  • Advancing Beyond CAPA Compliance, Using Innovation for Improvement and Growth - Part 135:29

    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.

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  • Advancing Beyond CAPA Using Innovation for Growth and Improvement

    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.

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  • How to Kick-Start Your CAPA Process

    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.

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  • Does Your CAPA Need a CAPA?

    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.

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  • How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance

    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.

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  • Clinical CAPA: Embedding Quality into Clinical Research

    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).

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  • Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment

    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.

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  • Simplifying CAPA: Seven Steps

    Simplifying CAPA: Seven Steps

    A comprehensive CAPA process consists of seven key actions that should be tracked and documented.

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  • 9 Free Resources to Boost Your CAPA Management System

    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.

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  • The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?

    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.

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  • MasterControl Field-Based Solutions (FBS) CAPA™

    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.

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  • MasterControl Supplier Corrective Action (SCAR)™

    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.

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  • MasterControl CAPA™

    MasterControl CAPA™

    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.

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  • CAPA Signs

    CAPA Signs

    Flier describes MasterControl's CAPA solution, outlining the features and benefits for users at different levels of an organization.

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  • Demo: MasterControl Customer Complaints/CAPA Management Software3:21

    Demo: MasterControl Customer Complaints/CAPA Management Software

    MasterControl complaint software streamlines the customer complaint process for improved safety and compliance.

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  • Quality Event Management and the CAPA System Part 2: Taking Effective Actions31:25

    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.

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  • Demo: MasterControl Clinical CAPA1:45

    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.

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  • Demo: MasterControl CAPA Software2:23

    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

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