Compliance

WHITE PAPERS AND CASE STUDIES

• 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.

• Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
• 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.

   

   

• 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.

• 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
• 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.

• AIIM 2004: In Comes Compliance, Out Goes The Cash As he made the rounds at AIIM Expo 2004, Chief Editor Tom von Gunden found vendors offering — and end users ready to buy — ECM, BPM, and ILM solutions targeting compliance-driven needs.
• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• 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.

• Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.