• How to Build and Maintain a Culture of Compliance

    This report provides a concise and clear framework for building and enabling the compliance management culture and processes.
  • Seven Steps to Effective CAPA

    When manufacturers capitalize on CAPA processes, they see vast improvements in process performance. An effective CAPA system is not only vital to compliance with regulations like the FDA’s QSR and ISO 13485 – it also is a key practice in achieving good product quality. Yet corrective and...
  • Three Key Strategies for Successful QMS: How to Integrate Quality into Company Culture

    Empowering quality functions helps organizations achieve compliance with regulations - standards like ISO 9001 and ISO 13485 emphasize company-wide commitment to quality. But beyond that, making quality a significant part of a company culture leads to the consistent production of safe, effective...
  • Build vs. Buy: Why Sharepoint Doesn’t Meet Document Control Demands for Quality and Compliance

    Although SharePoint provides features that you can use to build out your own rudimentary document management system, the costs of programming and IT support, maintenance and training as well as the possible legal ramifications due to the lack of verifiable audit trail make using SharePoint or...