INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.

  • CAP-IS (Compact Aseptic Processing Isolator System) is a cGMP Class A/ISO 5 isolation system, specifically designed for pharmaceutical production laboratories.

  • Explore automated electrophoresis solutions for vaccine development to ensure precise sample quality control and how these innovations streamline workflows and enhance reliability in vaccine research.

  • Use QX ONE Software Regulatory Edition, to assist in compliance with U.S. FDA 21 CFR Part 11 regulations when performing PCR experiments on the QX ONE System.

    QX ONE Software Regulatory Edition works in conjunction with the built-in security features of the Microsoft Windows 10 operating system to provide a security environment for the maintenance, verification, and tracking of all electronic records generated by the software. When properly configured and administered, these tools ensure compliance with the rules for secure handling of electronic records as outlined in Title 21, Part 11 of the Code of Federal Regulations (CFR).

  • Take control of your production by tracking every part, assembly, and batch with precision.