PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting

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Regulatory and Quality Intelligence

Posted on October 26, 2018 at 12:30 AM
An organization's ability to learn, and translate that learning into action rapidly, is the ultimate competitive advantage. Jack Welch There are 4 key attributes of successful compliant companies. 1. Rigorous internal audit program 2. Effective CAPA 3. Robust quality and regulatory intelligence system that provides knowledge needed to stay appraised of a dynamic regulatory environment 4. Commitment to act upon intelligence in timely manner. What is regulatory and quality intelligence? Regulatory information (oral or published) is the raw data used to create regulatory intelligence. Regulatory information can be internal (observations from internal and external audits) or external (guidance, regulations or regulatory trends). The data analysis, using data to create innovative strategies and integration into company corporate policies and procedures produces regulatory intelligence. Defining an effective regulatory intelligence system is critical. An effective regulatory intelligence system recognizes, tracks and ultimately predicted trends. There are 3 main step in any regulatory intelligence system, which are information gathering, information mining and transforming knowledge into actions. Regulatory intelligence helps timely and efficient product approval and maintenance. A good regulatory intelligence system ensures the continuous updates and improvement of existing quality systems based on evolving regulations and regulatory landscapes.

Categories: Current Regulatory Trends

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