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WHITE PAPERS AND CASE STUDIES

• Don’t Let Your MRO Inventory Manage You

  We've all been there; equipment breaks down and parts are ordered with little consideration as to lead time, price, quality, or reliability. This column offers insight into purchasing and managing MRO inventory.

• Validation Study In Adults With Lifestyle-Related Chronic Disease

  The Philips Health Band (PHB) is a wrist-worn activity and heart rate monitoring device. This study assessed the measurement performance of the PHB in adults at risk for lifestyle-related chronic disease such as cardiovascular disease and diabetes type 2 as well as adults with existing lifestyle-related chronic disease.

• Process Development For Scaled-up hESC/hiPSC Manufacturing

  A manufacturer faced a challenge to scale up, close and optimize a suspension-based manufacturing workflow for pluripotent stem cells (PSCs). In response, CCRM developed an optimized 14-day manufacturing workflow, which produces >10¹⁰, cells, in < 12 months.

• Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies

  The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

• Instrumentation Calibration As A Service

  One reality cutting across the entire range of processing plants and industries is the need for timely and proper instrument calibration. Instrument vendors with the right technical experience, established laboratories, and local, nationwide, or even worldwide reach can make the difference for this crucial task.

• How To Use FEKO With HyperMesh

  Users who would like to make use of the benefits of the advanced meshing features of HyperMesh while solving the electromagnetic aspects of the problem in FEKO, have several options to transfer the mesh from HyperMesh to CADFEKO.  

• Seal-Scan Medical Device Case Study

  High product costs and superior quality requirements are the two single reasons for successful integration of airborne ultrasound seal inspection for medical device packaging. This case study focuses on the use of Seal-Scan® for final seal quality verification for an implantable sterilized medical device.

• Making AI Usable For Pharma and Biopharma

  Artificial intelligence (AI) is already making a huge contribution to the global economy, even though this development is still in its early stages. AI is a kind of turbo drive for the new digital technologies, because it enables machines to imitate human decision-making processes. This white paper explores how to use artificial intelligence to uncover hidden business value in the regulated pharmaceutical and biotech industries.

• Tank Shark® Active Tank Mixing Proven To Be Superior To Dedicated Tank Inlet/Outlet Design

  San Jose Water Company (SJWC) provides drinking water for over a million people in the greater San Jose Metropolitan region and is a recognized leader in drinking water treatment and distribution system water quality management. With over 90 water storage facilities in service, planned maintenance and rehabilitation of capital assets is a key component of SJWC’s CIP program.

• Texas Cardiology Research Department Transforms Document Access, Fuels Productivity

  What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

• Specialized Ready-To-Use Food Manufacturer Installs X-Ray Inspection Systems For Quality Assurance Of Products

  When Edesia first opened its factory, the company used inline magnets in their processing line to find contaminants. When they realized they needed a better inspection system, metal detection wasn’t the answer because of the foil pouches used in the packaging process. So Edesia decided to incorporate x-ray into their production line.

• Ensuring Compliance With Part 11: A Site’s Perspective

  As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.