Compliance

PRODUCTS

  • AES Box™ is a modular architectural system that delivers our best-in-class modular cleanroom design and integrates seamlessly with your current project infrastructure while providing the compliance and quality you need.

  • Eliminate errors and accelerate production with MasterControl MES.

    MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.

    It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.

  • Drive your program forward with an experienced partner ready to execute early-phase clinical research with exceptional speed and scientific rigor.

  • Manage inspection-ready clinical trial documents with confidence for faster study execution with TrialKit’s electronic trial master file system.

  • PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model

WHITE PAPERS AND CASE STUDIES

  • 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.
  • Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support

    Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.

  • Pharma And Biotech: How Labs Achieve Data Integrity

    Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.

  • Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

    Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

  • California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
  • Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

    Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

  • GFI Case Study: Elgin Community College Uses GFI MailArchiver To Comply With E-Discovery Laws Elgin Community College is an educational institution in Elgin, Illinois offering first-class education from certificate to degree level. Changes to compliance and e-discovery regulations meant that the college required a system that allowed it to be in a position to provide electronic data should it be required as evidence in a civil or criminal legal case. To this end, the College installed GFI MailArchiver, an email management and archiving software.
  • Improving Global Labeling Workflow

    One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

  • Fire And Life Safety And Security Industry

    New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.

  • Why Compliance-Driven CDMOs Win Sponsor Contracts

    Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.

  • 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.
  • Intelligent Workflow From Farm To Processing At Dobler & Sons

    Dobler & Sons has incorporated a fleet management system to comply with the recent ELD mandate and to improve overall efficiency in managing it’s fleet and team of drivers.

NEWS