Compliance
PRODUCTS
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Drug safety is too important to entrust to underqualified teams or unpredictable models.
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Mikart has a solid foundation in pharmaceutical packaging services with over 45 years of experience manufacturing flexible configurations.
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Did you define your manufacturing contamination control strategy, or is it a collection of changes over time?
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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
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Polyzen is a premier manufacturer and supplier of low-pressure and high-pressure medical balloons in standard and custom sizes, shapes, and configurations.
WHITE PAPERS AND CASE STUDIES
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A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.
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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.
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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.
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Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
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Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
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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.
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Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
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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...
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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.
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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
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How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
NEWS
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Federal Equipment Company Announces Exclusive Sale Of Brand-New Aseptic Processing & Sterilization Equipment10/2/2025
Federal Equipment Company is pleased to announce the exclusive consignment of a suite of brand-new, never-used equipment designed for pharmaceutical and biotech aseptic processing. These state-of-the-art systems from leading manufacturers are now available for immediate purchase, offering buyers a unique opportunity to acquire high-performance technologies without the typical lead times of new builds.
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New GARDCO RTM Digital Micrometer7/1/2025
Paul N. Gardner USA (GARDCO) – worldwide distributors, producers, and designers of quality physical and inspection instruments for the paint, coatings, and related industries–announces its new offering the new RTM Digital Micrometer with the comprehensive RT Kit option.
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Rohde & Schwarz And U-Blox Validate Module Compliance With The New Chinese GNSS Automotive Specification GB/T2/26/2025
u-blox, a leading global supplier of GNSS modules, and Rohde & Schwarz have successfully validated ublox’s latest automotive GNSS module in accordance with the recently published Chinese GB/T test requirement for automotive on-board GNSS positioning systems using an automated R&S SMBV100B based GNSS simulator solution. This cutting-edge solution will be demonstrated at Mobile World Congress 2025 in Barcelona.
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Sun Chemical Secures RecyClass Approval For Four Solvent-Free Lamination Adhesives10/16/2025
Four of Sun Chemical’s SunLam solvent-free adhesives were approved by RecyClass for European flexible polyethylene (PE) recycling streams.
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NLMJ Technologies LLC Partners With ELD Mandate To Deliver ELD, HOS, GPS Fleet Tracking & AI Dashcam Solutions7/7/2025
NLMJ Technologies LLC, a Dallas-based innovator in fleet management technology, is proud to announce a strategic partnership with ELD Mandate, a nationally recognized provider of FMCSA-compliant electronic logging devices (ELDs) and GPS tracking systems.