Compliance

WHITE PAPERS AND CASE STUDIES

• How To Survive An FDA Audit

  Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

• Developing An Organizational Roadmap For Post Authorization Safety Studies

  Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.

• Case Study: DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
• 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.

• 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.

• Regulatory Compliance: Weighing In Pharma Manufacturing

  Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.

• Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support

  Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.

• Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
• Distribution Of The First Commercial CAR-T Therapy From USA To Japan

  Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.

• 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.

• 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.

• Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions