Compliance

WHITE PAPERS AND CASE STUDIES

• InnovaGel Gains Quick Return On Investment

  InnovaGel, a manufacturer of vitamins and supplements in the nutraceutical and OTC market, was in need of solution for its soft gelatin encapsulation machine application.

• Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support

  Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.

• 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.

• 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.

• A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

  Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

• GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
• Analytical Procedure (Method) Lifecycle Management Drives Method Development At Innovative CDMO

  A global CDMO proactively adopted MLCM and AQbD methodology to help their customers gain efficiencies, and improve the quality of their drug products, and the adoption of UPLC and PDA/QDa technology has contributed to its success.

• 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
• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
• Graniterock Speeds Up Reporting From 7 Days To Real Time

  Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.

• Adopting Label Change Best Practice To Promote Clarity And Compliance

  Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

• 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.