Compliance

WHITE PAPERS AND CASE STUDIES

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Operationalizing Disclosure Intelligence For Go-To-Market Success

  Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.

• Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control

  Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.

• 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.

• Security In The Supply Chain

  When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

• 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.

• Nemours Children's Health System Enhances Patient Experience With HID Global EPCS Solution

  HID Global Solution Enables DEA-compliant Electronic Prescriptions of Controlled Substances (EPCS)

• A Guide To Pharmaceutical Quality Management

  Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

• 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...
• 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.

• 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.

• Successfully Delivering Critical Stem Cell Samples Across The Globe

  To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.