Compliance

WHITE PAPERS AND CASE STUDIES

• AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
• Support Manufacturing Operations With Process Data Management Software

  Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).

• Intelligent Workflow From Farm To Processing At Dobler & Sons

  Dobler & Sons has incorporated a fleet management system to comply with the recent ELD mandate and to improve overall efficiency in managing it’s fleet and team of drivers.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

  Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

• A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
• Case Study: Success Of Saipan's Solid Waste Management System Serving As Example To Other South Pacific Islands An integrated solid waste management system implemented on the island of Saipan has proven so successful that other neighboring South Pacific islands may follow suit. The goal for a new solid waste system was to not only bring Saipan into compliance with federal environmental regulations, but also utilize state-of-the-art waste reduction and diversion technologies
• 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.
• 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.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• 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.