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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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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PHCbi brand's 24.2 cu.ft (684 L) upright pharmacy refrigerator offers a practical solution for storage with adjustable shelves and a wide setpoint range for varying laboratory applications, including biomedical storage and processing. The interior layout makes it ideal for running experiments that require changeable shelf configurations. The shelves can be arranged to accommodate all heights, and deep and strong enough to hold processing equipment and most devices.
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With a focus on sterile injectable drug development and manufacturing, August Bio provides deep industry expertise, brand new facilities and equipment, and comprehensive capabilities, delivered through collaborative partnerships between our clients and our engaged team of subject matter experts.
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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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Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
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Aligning Competing Interests While Optimizing The Service Chain In The Transportation Sector
This paper explores convergence in detail, starting with a breakdown of the service chain into its key components. We then discuss the obstacles and inherent consequences of inadequate efforts in each of these areas before presenting a model that helps set transportation companies up for success in service chain optimization.
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Strategic Hiring For Scalable Success
Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.
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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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Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
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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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TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
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AIIM 2004: In Comes Compliance, Out Goes The Cash As he made the rounds at AIIM Expo 2004, Chief Editor Tom von Gunden found vendors offering — and end users ready to buy — ECM, BPM, and ILM solutions targeting compliance-driven needs.
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Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control
Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.
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Sprint Helps Make Just About Any Place A Workplace
Driving down costs to remain competitive can be a tough challenge for transportation companies, especially in the face of increased fuel and insurance costs. At the same time, customer expectations are rising.
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Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.
NEWS
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New Sustainable Production Facility For Coatings For Direct Food Contact Materials Is Established In Indonesia8/19/2025
DIC Corporation announced today that it has established a new production facility for coatings suitable for direct food contact materials on the site of a plant belonging to PT.
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AERZEN Launches New BABA-Compliant Blowers6/6/2025
Aerzen USA is excited to announce the launch of its new Build America, Buy America (BABA) compliant blowers and controls. These blowers and controls are designed to meet the requirements of the BABA Act and support domestic manufacturing jobs.
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GIDR.ai Powers AI Glasses With Hands-Free AI Voice Guidance For Field Services5/19/2025
GIDR.ai, the Service Agentic AI Voice platform for guided intelligence, today announced the launch of GIDR powered AI Glasses, a groundbreaking, innovative initiative that enables field service teams with hands-free, AI voice guidance delivered through wearable smart glasses.
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KETOS Launches In-House Environmental Lab Testing For Water Quality4/23/2025
KETOS, a leader in automated water testing solutions, today announced KETOS Environmental Lab Platform, its new in-house Environmental Lab Testing Services for residential and commercial clients.
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New Flomatic AIS & BABA Compliant 12' Flo-Flex 745SC Surge-Stopper For Municipal And Industrial Water Systems11/12/2025
Flomatic Valves is proud to announce the official release of its new AIS (American Iron and Steel) and BABA (Build America, Buy America) Compliant 12” Flo-Flex 745SC Surge-Stopper.