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WHITE PAPERS AND CASE STUDIES

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
• High-Quality Serum to Improve Performance And Supply Stability

  A consultative partnership brought valuable solutions to a global CDMO that was experiencing performance issues with their fetal bovine serum, and needed a new product source of superior quality fast.

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Custom Microscope Objective Case Study

  Melles Griot custom objectives deliver superior imaging, color correction, and system repeatability—tailored for demanding applications where standard microscope optics fall short.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• 3 Themes And Takeaways From FDA's Draft Guidance On DCTs

  Get our experts’ summary of recent regulatory guidance as well as recommendations for optimal decentralized clinical trial design and conduct.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Isolator Vs. Optocoupler Technology

  While optocouplers have been the dominant signal isolation solution for a long time, a new breed of higher-performance CMOS isolator solutions will ultimately out-mode the venerable optocoupler.