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.

• Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination

  Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

• Leveraging Life Sciences Data For Intelligent Decision-Making

  Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• 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.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• A Guide For Quality Professionals In Healthcare And Life Sciences

  Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

• Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

  Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

• Agentic AI And How It's Impacting Clinical Trial Research

  Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.

• Designing For Diversity

  Embracing diversity enhances our understanding of humanity, fostering empathy and a broader perspective on the world's cultures and behaviors.