INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • 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.

  • The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.

  • Discover how microbial testing services can streamline QC workflows, ensure regulatory compliance, and reduce resource strain with tailored equipment and expert support.

  • The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  • The journey of a GLP-1 receptor agonist (GLP-1 RA) molecule is complex.