Compliance

WHITE PAPERS AND CASE STUDIES

• Advancing Compliance And Digital Strategy To Align With Pharma 4.0

  AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

• Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

  This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

• Maximize Output From Full-Time Employees

  Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.

• Safety First In The Field!

  Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

• Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
• Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan

  A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.

• 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.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• Comparative Analysis For Non-IND Sites

  A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

   

   

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.
• Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

  Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.