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  • Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…
    James A. Dunning, Owner, QPC Services LLC 08.15.17

  • Conquering Repeat CAPAs:  How an Automated Compliance Management System Helps

    Conquering Repeat CAPAs: How an Automated Compliance Management System Helps

    Today, the life sciences are faced with an enormous amount of competition and compliance challenges. More often than not, these issues escalate into the corrective action process before proper evaluation is made. This leads to routine problems, rathe…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 09.20.16

  • Four Questions to Help You Avoid Losing a CE Mark

    Four Questions to Help You Avoid Losing a CE Mark

    A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it applies to all device classifications. A company may have complied with the quality aspects of its ISO 13485…
    Patrick Biggins, Quality Assurance & Manufacturing, Musculoskeletal Clinical Regulatory Advisers LLC 08.09.16

  • Quality Is Everyone

    Quality Is Everyone's Business

    Outlining 10 reasons why the MES/MOM platform is best for manufacturing quality management.
    Francisco Almada Lobo 02.18.14

  • Machining & Tooling

    AAMI Develops Benchmarking Tool for Device Makers

    Platform designed to help companies measure quality management systems.
    10.23.13

  • A Complete CAPA

    Implementing an easy-to-use CAPA system offers many benefits to a medical device company. In addition to decreasing the likelihood of an FDA warning letter, a quality CAPA process helps ensure that your medical device organization is continuously i…
    08.05.13

  • Contract Manufacturing

    Quick CAPA Tips:

    Step 1—Know the Difference: Make sure you and your team understand the difference between a corrective action and a preventive action. While they can be handled within the same system, one is reactive (corrective) while the other…
    08.05.13