Compliance
PRODUCTS
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Compliance solutions for product development agility and audit readiness.
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Accelerate Medical Writing Without Compromising Accuracy or Compliance
In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.
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IntegriCell™ cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. Our state-of-the-art cryopreservation process, integrated with our end-to-end global temperature-controlled supply chain platform, provides unmatched reliability, efficiency, and scope. Our standardized protocols meet the highest compliance standards, ensuring consistent quality and addressing product stability issues associated with fresh donor-derived cellular material for an optimized approach that enhances manufacturing efficiency and streamlines operations.
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Streamline compliance processes and ensure your device history records are documented correctly the first time.
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Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?
WHITE PAPERS AND CASE STUDIES
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Medical Device Manufacturer Implements A Next-Gen MES
A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.
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TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
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Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine
As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.
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FoodTronix/PathwayLINK Case Study FoodTronix is a Dallas, Texas-based provider of "economical yet secure" POS solutions and a suite of technology products to restaurant market.
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Isn't The RFID Bandwagon Full? The RFID (radio frequency identification) space is a confusing market, and industry experts are not making it any more clear. Used with permission from Integrated Solutions Magazine
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PCI Compliance: Xirrus Releases Wi-Fi And Payment Card Industry (PCI) Compliance Whitepaper And Tools Xirrus, Inc., the only provider of high-performance, long-range Wi-Fi products, announced recently the availability of a new tool and whitepaper explaining the PCI (Payment Card Industry) Data Security Standard for companies that use Wi-Fi and handle payment card information.
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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.
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Data Collaboration Helps Novavax Accelerate Vaccine Production
How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.
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Security In The Supply Chain
When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical
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Leveraging AI For TMF Classification To Improve Quality, Consistency
Explore diverse AI methodologies, such as natural language processing and machine learning, elucidating how they seamlessly integrate with current systems to elevate efficiency and uphold quality standards.
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Mobile-Enabling Logistics: Turning The “Last Mile” Into Aa Competitive Advantage
When it comes to supply chain, the final process of actually delivering the goods can make or break a company. The impact associated with the delivery process affects margins, customer relationships, repeat business, and cash flow. The paper-laden delivery confirmation process often involves capturing key data and customer signatures, and then handing the paperwork to an admin for processing once the drivers are back at the office. This greatly impacts time to invoice, receiving of cash, revenue recognition compliance, and data quality.
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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.
NEWS
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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.
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Singota Solutions Expands European Footprint To 3 Sites, Adds New State-Of-The-Art Facility In Balerna, Switzerland3/25/2025
Singota Solutions, a trusted partner for pharmaceutical development and cGMP sterile drug product manufacturing as well as supply chain services, announces the opening of its new facility in Balerna, Switzerland.
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Introducing Acronis Archival Storage: A Long-Term Data Protection Solution1/13/2026
Acronis, a global leader in cybersecurity and data protection, today announced the launch of Acronis Archival Storage, a long-term, compliant, and cost-efficient data storage and protection solution designed for Managed Service Providers (MSPs) and their small-to-medium business (SMBs) customers.
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SwiftComply Launches Next-Gen Pretreatment Module, Setting A New Standard For Water Compliance6/18/2025
SwiftComply, the software platform built specifically for water utility compliance, today announced the launch of its new Pretreatment module, a specialized, smart system for managing industrial wastewater oversight.
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Rohde & Schwarz Launches High-Flexibility EMI Test Receivers At EMV2025 Paving The Way For Optimized Investments3/20/2025
The new EMI test receivers R&S EPL1001 up to 1 GHz and R&S EPL1007 up to 7.125 GHz offer engineers a flexible and cost-effective solution for EMI measurements.