Regulatory Articles

  1. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.

  2. Eliminating Data Integrity Errors Through Digitization 10/17/2022

    Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

  3. Meta Biomed Accelerates Digital Transformation Improving Collaboration 9/29/2022

    Learn how Meta Biomed implemented a solution to accelerate digital transformation, improve collaboration in a reliable, secure, and scalable cloud environment, and more. 

  4. 8 Best Practices For Compliant And Quick Software Validation In The Cloud 7/6/2022

    Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices. 

  5. The Future Of The FDA: Operating In An “Electronic World” 7/6/2022

    Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

  6. The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management 6/22/2022

    This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.

  7. Steps To Successfully Complete An FDA Inspection 6/20/2022

    We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

  8. How Early Raw Material Testing Mitigates Product Development & Regulatory Risk 6/7/2022

    Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.

  9. The Search For Control: Total Quality In Life Sciences 2/18/2022

    Bring data into one place to gain end-to-end visibility and traceability for total quality in every stage of research, development and manufacturing.

  10. How Effective Training Management Can Help You Prevent Quality Issues 1/28/2022

    Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.