Compliance
PRODUCTS
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Eliminate errors and accelerate production with MasterControl MES.
MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.
It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.
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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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Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.
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Qorvo's QPA0015 is a powerful Ku-Band MMIC amplifier fabricated using their advanced GaN-on-SiC process. Designed for Satcom applications, it delivers 3 Watts of linear power with excellent intermodulation distortion performance.
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An ultra-compact, and fully configurable, aseptic crimping platform, with capping force measurement, designed to help customers develop and manufacture new drugs and devices at low risk.
WHITE PAPERS AND CASE STUDIES
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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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Software Automation In The Blood And Biologics Industry
Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.
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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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Improving Global Labeling Workflow
One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.
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Case Study: 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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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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LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
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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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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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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.
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Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
NEWS
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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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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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airSlate SignNow And Paperwise Partner To Redefine eSignature And Workflow Automation3/10/2025
airSlate, a global leader in electronic signature and document workflow automation, is excited to announce a new integration and reseller partnership with Paperwise, a premier provider of process automation and document management solutions.
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MangoApps Adds AI-Powered Scheduling & Shift Swap To Its Extensive Workplace Operations App Marketplace7/15/2025
MangoApps today announced powerful new enhancements to its workplace operations platform, introducing AI-powered scheduling and intelligent shift swap capabilities.