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WHITE PAPERS AND CASE STUDIES

• 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.

• Food Traceability: Preventing Food Fraud And Ineffective Product Recalls

  With today’s complex food supply chain tracing products effectively is more critical than ever for food safety and quality, and more challenging. However, the industry is struggling to find an effective traceability system that would keep up with high production speeds. Flexible and modular traceability technology can solve this problem and help food manufacturers improve their processes, supply chain efficiency, emergency recall plan, without becoming a burden for production efficiency.

• Applying Variable Speed Compressors In Multiple Compressor Applications

  Variable speed control for all types of industrial equipment is readily available on the market with competitive pricing to non-variable speed controlled alternatives, including in the air compressor industry. With the advent of prescriptive rebate programs for variable speed compressors and other equipment, the demand for these types of controls has increased.

• Localz Enables Safelite Scan To Van

  The goal of the partnership between Localz and Safelite was to provide a digital solution to track their auxiliary stock items in the field, make it easy to replenish in the morning and to empower technicians to make value added sales during an appointment. Store managers are very busy and Safelite needed a simple, automated inventory management system for them to easily track stock in real time, manage the stock levels of each van and ensure technicians had the right stock on their van to support with a first time fix.

• Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research

  Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success.

• PSD (Position Sensing Detector) Characteristics

  Silicon photodetectors are commonly used for light power measurements but may also be utilized as optical position sensors. They are commonly referred to as Position Sensing Detectors or simply PSDs. This white paper discusses the different types of PSDs and their functions in different applications.

• Improving Field Operations Workflows

  To simplify and modernize its processes for gathering and referencing underground telecommunications infrastructure, ADP Resources leveraged the power of a cloud-based GIS solution that includes a robust suite of mobile apps that support the gathering of the necessary field data that planning and design teams rely on to facilitate design and permitting tasks. With accurate and up-to-date information readily available across the organization, ADP Resources' ability to meet and exceed the needs of its customers was drastically improved.

• LEAN Packaging Process Supports Pfizer’s Urgent Mission To Dose Child With Life Enhancing Gene Therapy

  Download this case study to discover how Almac’s LEAN packaging process supported Pfizer’s urgent mission to dose a child diagnosed with Duchenne Muscular Dystrophy (DMD), with a life enhancing gene therapy.

• Leader In Restorative Cell Therapies Embeds Skyland PIMS® As Process Knowledge Base From Clinical To Commercial Manufacturing

  A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.

• Avoiding Hemolysis Blood Sample Collection Processing

  Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided.

• 5 Future-Proof Capabilities Your FSM Platform Should Have

  FSOs are looking for solutions that will help them automate work order creation, scheduling/dispatch, location tracking, and time/labor tracking, and grow along with their business requirements. All future-proof solutions should include these five critical capabilities.

• 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.