Document Migration

PRODUCTS

  • Contamination Detection for Meat and Poultry Products

    The regulatory landscape is constantly evolving. Product inspection technology makes it easier to meet current requirements and provide cost effective solutions that can adapt to future needs. METTLER TOLEDO's metal detection and x-ray inspection solutions make it easier to overcome your foreign body detection challenges.

  • Pharmaceutical Asset Management & Reliability Services

    Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.

  • Medical Injection Molding

    Xcentric has supported injection molding for medical equipment for more than 20 years with rapid manufacturing services to help get products to market efficiently. Due to the importance of this role, Xcentric works very closely with clients’ design and procurement teams at every phase of each project to assure the delivery of quality components. The company also follows a streamlined production process to make sure the right people are in place from design to part.

  • Site Management And Clinical Monitoring

    Our Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site.

  • Commercial Manufacturing

    At Pii, quality is the foundation of everything we do. We strive to be a reliable commercial manufacturing and packaging partner by building exceptional quality systems matched by our well-designed facilities, proven technologies, broad expertise, and knowledgeable personnel.

WHITE PAPERS AND CASE STUDIES

  • Improve Your Traceability And Recall Capabilities

    With the release of recently updated FSMA requirements, F&B manufacturers have been forced to take a closer look at their existing processes and technology to help them achieve their business goals.

  • FSM Software Implementation Best Practices

    Enterprise software deployments are costly and complicated and come with significant risk. Gartner estimates that between 55 percent and 75 percent of ERP deployments fail to meet their objectives. In 2015, the Standish Group’s CHAOS Report claimed that just 29 percent of enterprise management information systems (MIS) projects were considered successful.

  • TMF Management Outsourcing Decision Guide: What To Know Before You Outsource Your Trial Master File

    This guide is designed to help life science organizations make an informed decision around a complex question: whether to outsource some or all of their Trial Master File management to a third-party provider. The questions and content in this guide will provide a solid framework for discussion, and set out key requirements to look for in a provider.

  • Engineering Into The Future: Modernizing With ArcGIS

    When San Juan Water District's (SJWD) legacy CAD-based geographic information system (GIS) lost its functionality to communicate across departments, it created bottlenecks and data silos. Collaboration became a struggle as staff began to rely on disparate datasets, paper map books, and outdated systems. It was time for a change. SJWD needed a solution that would repair the damage and, more importantly, ensure a sustainable future.

  • 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.

  • Reaching The TMF Health Zone: Expert Guidance From The TMF Authority

    Over the past 12-18 months, regulatory agencies have been increasing their focus around the Trial Master File and tightening their enforcement. In this white paper, we have summarized this extensive knowledge into core principles, to provide pragmatic guidance on how to best reach the TMF Health Zone.

  • How TechSmith Improves Products And User Experience While Growing Sales Via More Trial Conversions, Upgrades, Renewals, And Cross-Selling

    TechSmith regularly surveyed customers, but wanted to augment that data with comprehensive quantitative insight into product usage. Its own data collection system contained no reporting or analytics, frustrating product teams and the technical professionals tasked with operating and maintaining it. “Whenever we had a question our product teams had to ask a developer to stop work and write an SQL query," a strategy lead explained. Here's how TechSmith uses Revulytics to solve this challenge (and others).

  • Addressing The Evolving Needs Of Variable Drug Delivery Regimens

    Pharmaceutical companies continue to advance their clinical development pipelines to develop new and more sophisticated biologics. To be successful, they will need a solution that will enable the delivery and successful commercialization of complex biologics. This article describes a device designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.

  • Regulatory Robotic Process Automation: The Evolution From Compliance Enablement To Compliance Automation

    During the last 20 years, IT systems and software such as those used in regulatory, clinical, safety, and document management have been implemented across life sciences organizations. It has become clear that the benefits provided by the adoption of software and systems in the life sciences industry have reached a plateau. In this executive brief, we draw on our extensive experience helping leading pharmaceutical companies worldwide gain significant time and cost savings by implementing robotic process automation designed specifically for life sciences.

  • 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.

  • How The Best-In-Class Use AR For Superior Service Management

    Technician turnover continues to create challenges across the Field Service Management industry, and organizations are scrambling to keep up. Best-in-Class organizations are embracing emerging technologies like Augmented Reality (AR) to help manage these new workforce pressures. This report explores Augmented Reality successes, and charts a path to success for those businesses ready to embrace an augmented future.

  • 2020 North American Mobile Field Service Management Customer Value Leadership Award

    Field service management (FSM) is an industry that enables and supports service personnel as they travel to, and work onsite at, customer locations. FSM solutions are utilized across a broad swath of industries. Examples of field services include installation/maintenance/repair of equipment, utilities monitoring, at-home health care, construction services, insurance appraisals, etc. During the last decade, mobility has become an increasingly important component of FSM. With mobile access, field service organizations can use GPS and other technologies on their mobile handhelds (smartphones, tablets, rugged devices) to locate, manage, automate, and optimize their workers, tasks, and results anytime and anywhere.

NEWS