High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF

  Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.

• Demystifying Performance Testing: Strategies To Qualify Combination Products

  Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

• Home Furnishing Manufacturer Sleeps Soundly After Integrating CYBRA’s MarkMagic Labeling Solution With Manhattan SCALE

  Revman International’s investment in CYBRA’s MarkMagic paid for itself in less than six weeks.

• ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

  Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

• Harness Site-Based eISF For Remote Site Access And Monitoring

  The ability to access and collaborate with a research site is essential to the success of every study. A disconnected mix of on-site visits, email communications, and portals restrict site access and document exchange for Sponsors and CROs alike. Read how remote site access, source document review/verification and streamlined workflows transforms essential clinical trial processes.

• X-Ray Inspection Provides Product Safety For Ice Cream Production Lines

  To further reinforce positive customer experiences, an ice cream manufacturer challenged themselves to further minimize its already small risk of foreign body contamination by implementing x-ray inspection.

• inui Health Gets Results With EDC And eSource

  How a diagnostics startup drastically reduced timelines and costs, and easily shared data across dispersed sites.

• MSP Saves Time, Management Overhead With A Tailored Antivirus Solution

  Mirus IT was plagued by all the same problems that had aggravated the IT community for years. Heavy endpoint agents were causing major performance problems, upsetting clients and frustrating technicians. Kaspersky, their former antivirus solution, was becoming a major source of support tickets in its own right. With customers and employees alike, their existing antivirus was causing major headaches.

• Relying On Third Party Organizations For Strategic Equipment Acquisitions

  One of the most critical decisions for a pharmaceutical company is the choice to outsource operations, which leads to determining the optimal supplier with which to partner. When choosing an organization, a company must prioritize risk minimization and choose a dependable supplier with a strong track record. A facility is only as strong as the equipment that it runs, and production is only as effective as the equipment operators.

• How To Increase The Solubility And Bioavailability With Hot Melt Extrusion?

  When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.

• Duni Wipes Out Manual Work With MediusFlow

  Duni manufactures and distributes innovative tabletop concepts, creative packaging and take-away solutions for professionals and consumers in more than 40 countries across the globe. The company processes approximately 100,000 invoices per year through MediusFlow’s AP automation solution connected to SAP.

• Hydro-Electric Power Station Benefits From The Use Of Siemens Flow Meters

  Pumped storage hydro-electric power is a method of producing electricity to supply high peak power demands by moving water between water reservoirs at different elevations. At times of low electrical demand, excess generation capacity is used to pump water back into the higher reservoir. When there is higher demand, water is released back into the lower reservoir through a turbine. Pumped-storage schemes currently provide the most commercially important means of large-scale grid energy storage. Such systems greatly improve the daily capacity factor of power generating systems though out the world.