Healthcare

WHITE PAPERS AND CASE STUDIES

• Understanding And Implementing USP <665> For Single-Use Systems

  New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy

  Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.

• Rewriting The Future Of Clinical Trials

  In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development

• If Data Integrity Matters, Paper Is Not An Option

  Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.

• Novo Nordisk Harmonization Of Quality And Change Management

  See how Novo Nordisk, a global biopharmaceutical company, transitioned from a paper-based Quality Management System to an automated solution to enhance efficiency and compliance in change management.

• Tackling Antimicrobial Resistance

  Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• How LIMS Supports QC Scaling At Forge Biologics

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

• eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality

  Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• 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.