Compliance

WHITE PAPERS AND CASE STUDIES

• 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.

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

• Hospitality POS Reseller Relies on Mercury Payment Systems to Stay Ahead of the PCI Curve Partner education helps reseller overcome merchant objections.
• Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
• Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Trial

  Explore the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.

• Pharma Manufacturing: Top 10 Pitfalls To Avoid

  Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?

• Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM

  Explore how a U.S. biotech company uses RAM to centralize maintenance, calibration, and validation to improve compliance, efficiency, and visibility across multiple facilities.

• Mobile-Enabling Logistics: Turning The “Last Mile” Into Aa Competitive Advantage

  When it comes to supply chain, the final process of actually delivering the goods can make or break a company. The impact associated with the delivery process affects margins, customer relationships, repeat business, and cash flow. The paper-laden delivery confirmation process often involves capturing key data and customer signatures, and then handing the paperwork to an admin for processing once the drivers are back at the office. This greatly impacts time to invoice, receiving of cash, revenue recognition compliance, and data quality.

• 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.

• Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner

  In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.

• 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.

   

   

• 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