Records Management

WHITE PAPERS AND CASE STUDIES

• Regulatory Portfolio Management: From Bad To Gold

  Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• 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.

• Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection

  Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.

• The Future Is Now: CGT Innovation, Challenges, And Perspectives

  As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.

• PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt

  Learn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.

• Decoding A B-Cell Fingerprint: All You Need To Know

  Explore how, much like a fingerprint, each B-cell possesses a unique identity, and how deciphering this code can unlock a wealth of possibilities in antibody development, immunotherapy, and beyond.

• How A Pharma Company Improved Yield By 1.5% In Just Three Months

  A pharma company faced a 4% yield drop and variability at a manufacturing facility. Explore how they leveraged an AI-based platform to unify data, pinpoint inefficiencies, and enhance consistency in yields.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

  As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

• Revolutionizing Wastewater Management In Four Cities Through Water Mixing

  Historically, lift station operators have turned to chemical treatments as the primary means of managing grease buildup. However, these methods carry inherent drawbacks. 

• Xylem Factory Recycles 100% Of Its Process Water

  By leveraging natural surroundings, Xylem’s manufacturing facility in Emmaboda, Sweden, can recycle 100% of the plant’s process wastewater with its new water treatment. The plant helps ensure a continuous supply of safe water, even in times of water scarcity, using Xylem’s water reuse technologies.