Regulatory Compliance Solutions

31. Moving Visual Inspection Into Pharma 4.0 With The Identifier Software 8/25/2025

    Move your visual inspection processes into the Pharma 4.0 era with a digital system that provides data integrity and full audit trails to aid in compliance.

32. Biopharma Manufacturing Process Data Made Simple 9/6/2023

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

33. Advanced Real-Time Microbial Air Monitoring 2/13/2026

    Real-time environmental monitoring can streamline QC workflows. Learn how continuous particle detection and advanced microbial sampling support proactive contamination control and data-driven oversight.

34. U.S. Pharmaceutical Tariffs (Section 232): Implications & Actions 4/16/2026

    New U.S. tariffs are reshaping pharma manufacturing. Early action to assess exposure and pursue onshoring can cut risk, protect margins, and strengthen supply chains.

35. Application Guide For Plate Washers: Your Easy Way To Optimized Results 10/20/2025

    Explore how automated plate washers improve ELISA, bead-based, and cell-based assays with precision, flexibility, and reproducibility that is ideal for high-throughput labs seeking consistent results.

36. Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements 4/14/2023

    As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

37. Production Lifecycle, Bioprocess R&D, Scale-Up, Tech Transfer, Validation, And Mfg 8/21/2025

    Werum PAS-X Savvy accelerates bioprocessing with real-time data management, visualization, and analysis—enabling agile development, robust decision-making, cost reduction, and consistent quality across pharma and biotech production lifecycles.

38. Customizable Downflow Booths 2/26/2026

    Ensure operator safety and product purity with unidirectional airflow solutions. Explore how modular ISO 5 environments provide containment and cross-contamination control for critical processes.

39. Computerized System Validation Services 2/24/2025

    As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.

40. High-Quality Imaging For Up To Four-Color Microarrays On The GenePix Microarray Systems 6/21/2023

    Microarray scanners for one-fluor to multi-fluor applications

    The GenePix® Microarray Systems are based on 25 years of expertise in low-noise signal amplification and optical design. The systems can handle any slide-based microarray study, from small one- or two-fluor applications to multiple-fluor high-throughput projects requiring automated sample handling and secure enterprise-wide data management and analysis. All GenePix scanners include one license of GenePix Pro Image Acquisition and Analysis Software, the benchmark tool for the acquisition and analysis of microarray images.