Compliance
PRODUCTS
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The QPA1111 is a high-power, packaged X-band MMIC amplifier fabricated using a 0.15 µm GaN-on-SiC process for reliable, high-efficiency performance in demanding applications.
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Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.
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PHCbi brand’s 48.0 cu.ft. refrigerator with 10 solid pull-out drawers and forced-air circulation help helps ensures uniform temperature at all levels. The vertical airflow system delivers fast recovery after door openings, maintaining stability even in high-traffic environments. The automatic cycle defrost system minimizes temperature fluctuations while reducing maintenance. The temperature control system, with a microprocessor, maintains true temperature at the set level and is unaffected by outside ambient temperature. Audible and flashing LED visual alarms alert the user to the unlikely event of either a high or low temperature status.
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Expedite your development with our comprehensive suite of GMP services specifically designed to streamline regulatory and get you to market faster.
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Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.
They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.
Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.
WHITE PAPERS AND CASE STUDIES
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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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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.
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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.
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Serialization And Traceability Compliance In Pharma And Med Device
Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.
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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?
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Continuous Flow — An Emerging Alternative
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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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
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Sanford, FL Upgrades Water Treatment With Pinnacle Zenith 30X™ Ozone Generator
Sanford, Florida modernized WTP#2 with Pinnacle’s Zenith 30X™ ozone system, removing color, odor, DOC, and H₂S while improving energy efficiency and regulatory compliance.
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Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors
Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.
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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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Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
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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.
NEWS
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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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Smiths Interconnect Launches EZiCoax, Single-Piece Coax For Interposer Solutions7/23/2025
Smiths Interconnect proudly announced today the launch of EZiCoax, a single-piece, compression mount, 50-ohm RF coaxial contact for use in board-to-board signal transmissions.
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eGain Announces Enterprise AI Platform Connectors For Copilot, Claude, Gemini, And Cursor4/7/2026
eGain (NASDAQ: EGAN) today announced new enterprise AI platform connectors that integrate Microsoft Copilot, Anthropic Claude, Google Gemini CLI, and Cursor with eGain AI Knowledge Hub, the company’s AI-powered knowledge management platform.
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New Automated Cybersecurity Testing For Embedded Software Available In Compliance With RED EN18031 Standard7/23/2025
Starting in August of this year, connected digital products will be required to comply with the EU Directive RED (Radio Equipment Directive) EN 18031. In response, Düsseldorf-based cybersecurity company ONEKEY has integrated testing for RED EN 18031-1 into its automated cybersecurity platform.
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R2 Recycling Makes E-Waste Recycling Simple And Hassle-Free For New York City9/12/2025
R2 Recycling, a trusted name in responsible electronics recycling, is proud to announce expanded, hassle-free e-waste recycling services across all five boroughs of New York City.