Compliance

PRODUCTS

  • Eurofins PSS Insourcing Solutions delivers comprehensive manufacturing support that meets production goals with precision, compliance, and agility for biotech, pharmaceutical, and CDMO organizations. Our insourcing model places fully trained, managed scientific teams directly at client sites, enabling seamless integration into manufacturing operations while maintaining flexibility and long-term stability.

  • Germfree’s compliant modular compounding pharmacies offers non-hazardous and hazardous drug compounding within our established modular platform. It enables hospital pharmacies to manage surges, maintain patient support during renovations, and enhance efficiency with Germfree’s cutting-edge modular hospital compounding pharmacy.

  • PHCbi brand's 3.0 cu.ft. (85 L) undercounter refrigerator is designed to be incorporated into ADA compliant workspaces and fits under most tables, cabinets, and benches. Its convenient glass door provides visibility into the interior of the unit to avoid unnecessary door openings. Temperature performance for your critical storage items in your tight spaces.  Units can be stacked with an adapter to maximize valuable laboratory floor space. This space-saving lab refrigerator includes an automatic defrost function and is ENERGY STAR® certified.

  • The AMP20072 is a solid-state high power amplifier designed for a wide range of applications including EMI/RFI testing, laboratory work, continuous wave (CW) and pulse operations, and general communication use.

  • Compliance solutions for product development agility and audit readiness.

WHITE PAPERS AND CASE STUDIES

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • 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.

  • Client Story: Efficiency Enabling CSV At Scale

    Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

  • USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
  • How ABB's Flow And Digital Technologies Help Bawat With Smarter Ballast Water Compliance

    The International Maritime Organization (IMO) sets strict global standards for ballast water management to prevent the spread of harmful aquatic organisms. For companies like Bawat, a Danish innovator in ballast water management, being able to verify ballast water flow measurements quickly, accurately, and from anywhere in the world is essential.

  • A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
  • Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours

    The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.

  • Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  • Replacing A Paper-Based GMP System With An Electronic Monitoring System

    As a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics' sought to replace an its paper-based GMP record system and manual process with an electronic monitoring system.

  • 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: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
  • Preparing For Post-Market Clinical Follow-Up Under EU MDR

    Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

NEWS