Compliance
PRODUCTS
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With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.
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The AES modular cleanroom system is engineered with inherent flexibility to seamlessly incorporate essential modular cleanroom accessories while maintaining structural integrity and eliminating the need for costly engineering rework.
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The Qorvo QM33120WDK2 Ultra-Wideband Development Kit is an all-in-one solution for developers and engineers working on UWB (Ultra-Wideband) product development and demonstrations.
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120Water creates an easy, resident-friendly experience that takes the hassle out of compliance sampling for you. From easy-to-use kits and comprehensive collection support, to data collection and reporting, our team can lighten the load of your next monitoring period.
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Our rotary turret uses proven tablet-press -based, principles. It progressively compresses powder into small pockets on a continuously rotating disk using a combination of rotors and pins. The resultant doses are then transferred to blister strip as it passes underneath the disk.
WHITE PAPERS AND CASE STUDIES
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Virtual Study Yields High Compliance & Retention Rates
Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.
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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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Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
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Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing
Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.
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White Paper: The Impact Of The Internet On Compliance Education I sat with astonishment as the compliance officer of a large corporation told me that he had no idea what compliance education was being performed on a day-to-day basis within his organization. He went on to indicate that his company could not produce reliable documented evidence that its employees had in fact, completed federally mandated education
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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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Successfully Delivering Critical Stem Cell Samples Across The Globe
To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.
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DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
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Case Study: DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
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Ensuring Compliance With Part 11: A Site's Perspective
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.
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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.
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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.
NEWS
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BlueFletch Pioneers Integration With Microsoft's QR Code + PIN Authentication For Frontline Workers2/25/2025
BlueFletch, a leading provider of secure enterprise mobility solutions, announces its pioneering integration with Microsoft's QR Code + PIN authentication method.
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Cade & Associates Launch Managed Human Resource Services2/12/2025
Cade & Associates is proud to announce the launch of its Managed Human Resource Services, a comprehensive solution designed to simplify HR management for businesses of all sizes.
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Recipharm Expands Aseptic Filling Capabilities For Process Development, Pilot Scale And Clinical Supply2/5/2025
Recipharm, a leading global contract development and manufacturing organisation (CDMO), has announced that a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany.
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Gnosko Launches RFID-Integrated Chain Of Custody Platform To Help Labs Do More With Less5/20/2025
As laboratories face shrinking research budgets, government funding cuts, and increasing compliance demands, Gnosko is stepping up with a timely solution: a cost-effective, RFID-integrated Chain of Custody (CoC) platform that automates sample tracking, inventory management, and regulatory reporting.
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Sentinel Water Solutions And DESOTEC Announce Partnership To Provide NSF-Certified GAC Reactivation Services8/26/2025
Sentinel Water Solutions (Sentinel), a leader in PFAS pilot testing and treatment, today announced an exclusive channel partnership with DESOTEC, one of the world’s leading providers of sustainable activated carbon solutions, to deliver NSF-certified granular activated carbon (GAC) reactivation services for U.S. drinking water utilities.