Healthcare

WHITE PAPERS AND CASE STUDIES

• Scaling Safe, Consistent Drug Delivery in Modern Care

   Assistive drug delivery technologies, including wearable injectors, smart infusion systems, and guided delivery tools, help standardize dosing, reduce variability, and expand access across care settings.

• Advancing QC Efficiency With SEC-MALS System And Empower Software

  Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.

• 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.

• Meeting The FDA's New Real-World Evidence Standards

  FDA guidance is reshaping RWE strategy. Sponsors that build interoperable, audit-ready RWD infrastructure now will be best positioned for faster, defensible submissions.

• Transforming Clinical Trial Management

  See how Vestigo^® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.

• Creating Sustainable Data In The Laboratory

  In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.

• 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.

• Science With Purpose: Advancing Sustainability In Biopharma Testing

  Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• What FDA CRLs Reveal About Method Validation

  FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.