Compliance

WHITE PAPERS AND CASE STUDIES

• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine

  As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.

• 8 Questions to Ask When Evaluating An MES

  Explore the purpose and value of MES solutions and walk through eight of the top questions to ask when evaluating an MES for your organization.

• Continuous Flow — An Emerging Alternative

  Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

• Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

  The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

• Eliminating Data Integrity Errors Through Digitization

  Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

• 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.

• Client Story: Efficiency Enabling CSV At Scale

  Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

• Sprint Helps Make Just About Any Place A Workplace

  Driving down costs to remain competitive can be a tough challenge for transportation companies, especially in the face of increased fuel and insurance costs. At the same time, customer expectations are rising.

• 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.

• PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
• GFI Case Study: Elgin Community College Uses GFI MailArchiver To Comply With E-Discovery Laws Elgin Community College is an educational institution in Elgin, Illinois offering first-class education from certificate to degree level. Changes to compliance and e-discovery regulations meant that the college required a system that allowed it to be in a position to provide electronic data should it be required as evidence in a civil or criminal legal case. To this end, the College installed GFI MailArchiver, an email management and archiving software.