Compliance
PRODUCTS
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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 48.2 cu.ft., refrigerator with 8 adjustable shelves and a forced-air circulation for maximum temperature uniformity at all levels. Unique electronic defrost cycle initiates defrost function automatically, minimizing temperature fluctuation during the process. 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. High performance refrigeration system with reserve cooling capacity assures fast recovery following door openings.
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25 years of Providing World-Class Medical Information Services.
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The MPD4-0218CSP3 from Marki Microwave is a compact, chip-scale packaged (CSP3) 2–18 GHz MMIC 4-way power divider/power splitter that delivers exceptional RF performance in a small footprint.
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PHCbi brand's 8.4 cu.ft. (238 L) compact microbiological heated and cooled incubator is designed to helps ensure highly accurate, reproducible environments that mimic real-world conditions. It offers precise control of temperature, a low humidity setting, and lighting protocols - making it ideal for microbiology testing and research, food and cosmetic shelf life testing, municipal wastewater testing, plant cell culturing, and more. It is completely programmable, allowing for direct numeric input with memory of operation, start dates and hours, clock mode and timer.
WHITE PAPERS AND CASE STUDIES
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Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
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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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Hyland Software Customer Rochdale Metropolitan Borough Council Presents At Butler Group Enterprise Content Management Symposium In London Hyland Software, Inc., developer of the OnBase enterprise content management (ECM) software suite, announced that Hyland customer Rochdale Borough Metropolitan Council presented a case study regarding its installation of OnBase at the Butler Group Enterprise Content Management Symposium.
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Support Manufacturing Operations With Process Data Management Software
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
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Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
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Electronic Informed Consent: Considerations For Implementation In Clinical Trials
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
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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.
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24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
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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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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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Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions
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Making Money With Security Awareness Training
How addressing human error reduces risk and bolsters your profitability.
NEWS
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My Visit Revolutionizes Field Management With Accurate Visit Tracker And EVV Tools6/5/2025
In an increasingly mobile and compliance-driven world, My Visit introduces a transformative solution for businesses and service providers that need to track field activity, manage mobile teams, and meet regulatory standards.
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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.
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Sun Chemical Secures RecyClass Approval For Four Solvent-Free Lamination Adhesives10/16/2025
Four of Sun Chemical’s SunLam solvent-free adhesives were approved by RecyClass for European flexible polyethylene (PE) recycling streams.
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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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Rise Expands Employer Of Record Services To Revolutionize Global Hiring And Payroll Compliance4/3/2025
Rise, the pioneering Web3-enabled payroll and compliance platform, has announced the expansion of its Employer of Record (EOR) services, enabling businesses to seamlessly hire full-time employees across borders without the need to establish local entities.