Compliance
PRODUCTS
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Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 43.5% R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.
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Providing around-the-clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk.
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The MM1-0626SSM is a highly linear passive GaAs double balanced MMIC mixer suitable for both up and down-conversion applications.
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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.
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Verista’s team of experts understand and implement industry leading strategies that balance risk while delivery solutions in the most efficient manner. Their goal is to meet client needs through establishing and restructuring a best-in-class compliant and efficient Quality Management System (QMS).
WHITE PAPERS AND CASE STUDIES
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Cabrini Health Experiences Improved Operational Efficiency And Other Significant Benefits With triCerat
Cabrini Health is a not-for-profit Catholic healthcare service with 3,800 employees and over 700 beds comprising of two acute care hospitals, a palliative care service, rehabilitation hospital, residential care facility, and pharmacy department.
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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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WIMAX With Differentiation By Elvis Tucker, Aperto Networks
The WiMAX Forum defines the profiles that any WiMAX-compliant broadband wireless access systems must support in order to achieve inter-operability. But while inter-operability is an important goal for any WIMAX-compliant system, it will not ensure optimization. Submitted by Aperto Networks
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Secure Storage: A Necessary Evolution All large organizations have gone to great lengths to protect their information assets. All kinds of security systems, from network firewalls and VPNs to passwords and physical mechanisms have been implemented to prevent unauthorized access to networks and premises. Submitted by Nexsan Technologies, Inc.
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Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
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Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support
Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.
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California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
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Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
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A Survival Guide To Temperature Data In Life Sciences
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
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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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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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A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.
NEWS
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EZ LYNK's ELD Technology Achieves Certification In Canada, Streamlining Compliance And Enhancing Fleet Efficiency12/19/2024
EZ LYNK, a leader in connected vehicle technologies, today announced that its Electronic Logging Device (ELD) technology received certification for compliance with Canada’s ELD mandate.
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AppTec360's Advanced Mobile Content Management Solutions Reinforce Enterprise Security3/11/2025
Data security remains a critical concern for organizations as the risk of breaches and unauthorized information sharing continues to rise. Addressing these challenges, AppTec360 introduces ContentBox, a Mobile Content Management (MCM) solution designed to enhance security while enabling seamless file synchronization and controlled data access.
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With Click Rate Analysis, The R&S EPL1000 EMI Test Receiver Is The Cost-Effective Answer To CISPR 14-1 Compliance Testing3/1/2024
For both device developers and conformance test houses the R&S EPL1000 EMI test receiver offers fast, accurate and reliable EMI compliance measurements up to 30 MHz at the best price in its class. The R&S EPL1000 now adds click rate measurements in line with the latest CISPR 14-1:2020 version, mandatory for household appliances and electric power tools.
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Selkirk Pharma Announces New APS Qualified Facility With Advanced Fill/Finish Capacity In Spokane, WA2/15/2024
Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity.