Document Migration

WHITE PAPERS AND CASE STUDIES

• 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.

• 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.

• A Toolbox For An Effective Tech Transfer

  As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.

• 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.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Endpoint Clinical RTSM: Getting The Job Done

  Explore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Innovative FSP Solutions For Biopharma Growth And Transition

  To optimize clinical development, the pharmaceutical industry is increasingly adopting innovative outsourcing strategies with CROs.

• Sickle Cell Cure Within Reach, But At A Steep Cost

  Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.

• Taking The First Step In Creating An Intelligent Laboratory

  Learn how the implementation of a lab management system has enabled one company to accelerate its operations and initiate its journey toward establishing a truly intelligent laboratory.