Compliance

PRODUCTS

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    Qualified Person For Pharmacovigilance (QPPV)

    Gain expert guidance and connect with a global network of qualified QPPVs and LPPVs, who will ensure compliance with pharmacovigilance regulations and tailor their approach to your product launch strategy.

  • ViralVectors
    Cleanrooms And Equipment For Viral Vector Drug Manufacturing

    Viral vector manufacturing: key to successful gene therapy

    Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

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    Altasciences' Commitment To Animal Welfare

    We maintain an unwavering focus on the welfare of the laboratory animals in our care. Our entire preclinical staff is trained in laboratory animal care and focused on animal welfare and environmental enrichment — embracing compassion, sensitivity and adherence to regulatory guidelines.

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    Process Analytical Technology For In-line Bioprocess Analysis

    This easy-to-use process analytical technology device offers in-line bioprocess analysis and control with no complex modeling. Measure multiple critical parameters across media, across processes, across mammalian cell lines, across scales.

    All In-line Gain, No Modeling Pain

    MAVERICK is powered by Raman spectroscopy and a purpose-built de novo model. The de novo model is explicitly built on media chemistries and device physics, not on empirical data. It automatically interprets the spectra and quantifies process parameters enabling simultaneous measurements of glucose, lactate, and total biomass. This is achieved without the costs, complexities, and risks associated with conventional Process Analytical Technology (PAT) methods. There is no need to grapple with complex empirical models, reagents, or unreliable auto-sampling systems to implement in-line bioprocess analysis.

  • Vaccines
    Cleanrooms And Equipment For Vaccine Drug Manufacturing

    Solutions for rapid response to vaccine development and manufacturing challenges

    Vaccine development trends emphasize the need for adaptability and accessible production facilities. Remote manufacturing tackles these challenges, facilitating decentralized vaccine production and rapid responses to health crises. Germfree, a leading cleanroom manufacturer, remains at the forefront of these trends by providing configurable solutions that satisfy regulatory requirements and end-user needs. By leveraging innovative remote manufacturing technologies, Germfree helps shape a more dynamic and efficient future for vaccine development and production.

WHITE PAPERS AND CASE STUDIES

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    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.

  • Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
  • 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
  • How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives

    This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3

  • 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.

  • Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
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    Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

    The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

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    Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing

    Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.

  • Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
  • 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.
  • Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
  • Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx

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