Compliance

PRODUCTS

  • Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

    They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

    Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.

  • GFRMC panels are primarily used in the production of 40-foot mobile labs and mini labs. Due to their weight and the efficacy of the Dry Build installation process, GFRMC panels are also used to construct cleanrooms in challenging or remote locations.

  • Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.

  • It’s about time.
    Modern eConsent.
    Solved.

    Deliver complex eConsent experiences that participants will love. Drive compliance and retention with truly informed participants, using a system that is easy to configure and manage from site to subject.

  • Arcoplast solid core service doors offer superior durability and hygiene. Their innovative design and easy-to-clean surface make them the ideal choice for demanding environments.

WHITE PAPERS AND CASE STUDIES

  • PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
  • Security In The Supply Chain

    When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

  • Cabrini Health Experiences Improved Operational Efficiency And Other Significant Benefits With triCerat

    Cabrini Health is a not-for-profit Catholic healthcare service with 3,800 employees and over 700 beds comprising of two acute care hospitals, a palliative care service, rehabilitation hospital, residential care facility, and pharmacy department.

  • Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

    The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

  • A Guide To Pharmaceutical Quality Management

    Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

  • Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
  • ARMA 2005 Show Highlights Refined Solutions For Records Managers The message to attendees of this year's ARMA show was to engineer an easy transition from paper-based files to electronic records management, supported with a clear and calculated plan. ARMA provided me a chance to sit down and talk with ECM vendors about the special offerings they had for solving companies' records management needs. Check out some of news and highlights from the manufacturers and software providers that were at the show.
  • Successfully Delivering Critical Stem Cell Samples Across The Globe

    To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.

  • Validation Provider Shortens The Path To Equipment Qualification

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  • 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.

  • Solutions To Global Pharmaceutical Supply Chain Challenges

    The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.

NEWS