INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.

  • Automated microbial screening system capable of picking up to 3,000 colonies per hour

    The QPix® Microbial Colony Picker leverages best-in-class colony picking technology to alleviate bottlenecks and quickly, accurately, and efficiently screen through massive genetic libraries. The easy-to-use, intuitive software guides users through setting up colony picking runs where precision robotics pick the right colonies every time.. In addition to microbial screening, the system automates several sample preparation and plate handling processes such as transfer of bacterial liquid culture and plating on agar.

  • Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.

  • As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.

  • From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.