Compliance

PRODUCTS

  • AES has transformed the landscape of modular cleanroom design, manufacturing and construction. What began as a vision to elevate industry standards has evolved into a legacy of cleanroom solutions that protect the world’s most critical processes.

  • As the time, costs and complexity of cleaning validation challenges grow, savvy life sciences companies are building a competitive advantage around smarter approaches to cleaning validation.

  • The RADIOSAFE Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. An optional thimble connection allows for external ducting of the exhaust air.

    The Class II Type A RADIOSAFE Series of Biosafety Cabinets meets all requirements for USP 825 compliance and is constructed from 100% Stainless Steel.

  • As cell and gene therapies continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves.

  • The MM1-1886HCSP2 is a highly linear passive GaAs double balanced MMIC mixer suitable for both up and down-conversion applications.

WHITE PAPERS AND CASE STUDIES

  • Graniterock Speeds Up Reporting From 7 Days To Real Time

    Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.

  • Protecting Cardholder Data In The Enterprise Retail Market Merchants are feeling increased pressure from credit card companies to comply with security regulations such as the Payment Card Industry (PCI) Data Security Standard (DSS) and Payment Applications Best Practices (PABP) and are being offered incentives to comply or facing harsh penalties for not complying. Submitted by IP Commerce
  • The Importance Of Quality In Raw Material Selection

    Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

  • 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.

  • Developing An Organizational Roadmap For Post Authorization Safety Studies

    Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.

  • How An MSP Enhances Compliance For Healthcare And Finance Clients

    Eric Gaffin is the Director of Cybersecurity and Compliance Services for Advanced Technology Group, a managed security and IT services company with a 20-year track record of delivering cutting edge solutions to clients in heavily-regulated industries. See how he’s using ActivTrak to address his clients’ compliance needs.

  • Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

  • Operationalizing Disclosure Intelligence For Go-To-Market Success

    Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.

  • GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
  • 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.

  • 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...
  • Analytical Procedure (Method) Lifecycle Management Drives Method Development At Innovative CDMO

    A global CDMO proactively adopted MLCM and AQbD methodology to help their customers gain efficiencies, and improve the quality of their drug products, and the adoption of UPLC and PDA/QDa technology has contributed to its success.

NEWS