Maintenance / Service

WHITE PAPERS AND CASE STUDIES

• Delivering Value Across Sites With Unified Quality Operations

  Standardizing quality processes across 14 sites has enabled faster lead times. Discover how a unified platform reduces complexity, improves compliance, and delivers greater value for customers.

• Novel Platform For Execution Of Pragmatic Studies Boosts Cancer Trial Efficiency

  Learn how Flatiron partnered with Genentech and Foundation Medicine to develop a novel platform for the execution of pragmatic studies.

• Drilling Down On Diversity And Feasibility

  A mid-sized contract research organization (CRO) sought help with writing clinical trial diversity action plans and assessing feasibility for therapeutic areas outside its usual scope.

• 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.

• 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.

• Forget About Isolators: Switching From Manual Vial To Automated Bag Filling

  Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• Incremental Adoption Of A Modular Operations Platform

  Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs

  Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

• Transformative Innovation: Advancing Drug Development Using In Silico Modeling

  Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.