Compliance

WHITE PAPERS AND CASE STUDIES

• Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations

  Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.

• Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours

  The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.

• 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
• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• 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.

• LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
• How An MSP Enhances Compliance For Healthcare And Finance Clients

  Eric Gaffin is the Director of Cybersecurity and Compliance Services for Advanced Technology Group, a managed security and IT services company with a 20-year track record of delivering cutting edge solutions to clients in heavily-regulated industries. See how he’s using ActivTrak to address his clients’ compliance needs.

• 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
• Hyland Software Customer Rochdale Metropolitan Borough Council Presents At Butler Group Enterprise Content Management Symposium In London Hyland Software, Inc., developer of the OnBase enterprise content management (ECM) software suite, announced that Hyland customer Rochdale Borough Metropolitan Council presented a case study regarding its installation of OnBase at the Butler Group Enterprise Content Management Symposium.
• 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).

• 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.

• Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies