Healthcare

WHITE PAPERS AND CASE STUDIES

• Providing Enhanced Manufacturing Data To Contracting Companies

  The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

• Maintaining Quality And Regulatory Compliance To Support Rapid Global Growth

  Discover how Huvepharma, a global pharmaceutical company, implemented software to standardize quality management processes across its manufacturing sites, enhancing compliance and efficiency.

• Quality: The Link Between Platform, Processes, And Patients

  Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.

• The Evolution Of Clinical Operations And The Growth Of FSP Partnerships

  Explore the integration of new technologies, the FSP’s role in promoting patient diversity, and how clinical operations leaders are increasingly becoming thought leaders within the industry.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• Inline Checkweighing Of Packaged Products In Manufacturing

  Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

• Don't Let Formulation Failures Derail Drug Development

  In the face of increasing molecular complexity, early developability assessment with a skilled CDMO can reduce pharmaceutical development costs, prevent clinical delays, and improve commercial success.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• 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.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.