Compliance

WHITE PAPERS AND CASE STUDIES

• 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)

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

  Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

• Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

  Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

• Connected. Intelligent. Compliant. The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• Building The Business Case For LIMS

  Explore how digital workflows and automation deliver measurable ROI and competitive advantage for life sciences organizations navigating complex manufacturing challenges.

• 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.

• 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.

• Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
• Protect Your Health Records And Meet Your Compliance Obligations White Paper: HIPAA And Assureon
• 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.

• 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.