Government

WHITE PAPERS AND CASE STUDIES

• How LIMS Supports QC Scaling At Forge Biologics

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• Navigating The FDA's Drug Supply Chain Security Act

  Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

• Connecting Quality Management, Patient-Centricity, And Business Value

  Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

• 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.

• A New, AI-Augmented Horizon For Safety And Pharmacovigilance

  Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.

• Criticality And Risk Analysis Helps Mojave Water Agency Optimize Maintenance Activities And Realize Cost Savings

  Amid a decrease in water supply and reliability, the MWA has seen a rise in costs and operational challenges related to regional expansion, increased regulatory requirements, climate change, and aging infrastructures. Despite these challenges, the MWA remains committed to managing groundwater basins sustainably, importing water responsibly, and proactively addressing risks using sound scientific practices.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

  Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.