INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

  • Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.

  • Ensure the highest quality and sterility for your injectable manufacturing with proven aseptic expertise. Expect customer-first service, regulatory excellence, and a commitment to long-term success.

  • Explore how standardized PCDs improve sterilization reliability, reduce costs, and support regulatory compliance, as well as technology that offers more consistent EO sterilization validation.

  • Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation

    SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.