High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• The Electronic Trial Master File: Study Item And Placeholder Analysis

  Electronic trial master file (eTMF) systems are proving to be effective in planning, managing, monitoring, and maintaining inspection-readiness and compliance. This paper explores the use of planning wizards and how placeholder creation promotes study completeness, timely document uploading, and reduced rates of quality control failures. These features can ease workloads while providing the transparency needed for inspections and audits.

• 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.

• TASKMASTER® Multi-Stage Shredding System for Pharmaceutical Plant Security

  A pharmaceutical manufacturer was faced with major waste management concerns. They urgently needed a powerful shredding system capable of quickly and efficiently reducing bulky pharmaceutical rejects, packaging and literature to an unrecognizable condition. The company had recently purchased shredding equipment to replace older units, which were failing, but soon encountered unexpected problems. Pharmaceutical material passing through the carbon steel shredders often contained corrosive chemicals, which eventually eroded the units.

• 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.

• AI-Assisted Indexing Improves TMF Management

  The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. In this case study, you can learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while maintaining 98% accuracy.

• Qorvo Helps Xiaomi Reap Full Potential Of Wi-Fi 6

  As a leader in RF technologies, Qorvo offers unique insights on Wi-Fi 6 router solutions. Xiaomi’s recently launched AX1800 Wi-Fi 6 router used Qorvo technology strength to the fullest. As Xiaomi designed its latest router, they partnered with Qorvo to leverage our RF technology and Wi-Fi 6 expertise to overcome some key challenges.
   

• Save Space With Single-Use Bags, Secondary Packaging Solution

  Find out how a multinational biopharma company overcame a diminished shipping capacity challenge after switching to single-use bags to improve storage capacity at one of its production sites.

• How A Sponsor Secured 200 High-Performing Investigators In Just 5 Days

  A research sponsor was planning to conduct a clinical trial to study a new drug to treat kidney disease. The clinical operations team anticipated needing 200 high performing investigators—and quickly. However, this was a new area of investigation for the sponsor, leaving them unable to leverage existing site relationships. Learn how with our proprietary data solution, the partners quickly identified a pool of investigators who possessed the appropriate interest in clinical research, the requisite medical experience and expertise, and the necessary infrastructure to support a clinical trial.

• Managing Risk In Single-Use Systems Design And Implementation

  Ultimate responsibility for drug processes and products always will remain with manufacturers. However, implementation of SUS can shift responsibilities to SUT suppliers within key areas, including design and sterilization methods that must be controlled and validated. Read more about the roles of the supplier and the customer in order to mitigate risk and advance innovation.

• Drop-In Purification For Removal Of Aggregates From Antibody Therapeutics

  A client's product contained high aggregate levels following affinity capture. Chromatography helped, but product loss in elution buffers and stat in-process assays ensued. Here's how they solved the problem.

• Modular Bioprocessing Alleviates Drug Manufacturing Woes

  Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

• Zygo Accumold Case Study

  Accumold is a pre-eminent micro molding company experienced in fabricating precision micro, small, and lead-free injection-molded plastic components. Accumold relies on ZYGO coherence scanning interferometer equipment to maximize efficiency.