Compliance
PRODUCTS
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Mikart has a solid foundation in pharmaceutical packaging services with over 45 years of experience manufacturing flexible configurations.
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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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Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.
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Capture data at the true source: the patient. Improve the patient experience with secure, accessible questionnaires both via email and through the Castor Connect mobile application.
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Create an aseptic workspace with Ecolab’s Bioquell Qube, a configurable isolator integrated with Bioquell Hydrogen Peroxide Sterilant*. From its unique design to rapid turnaround time, the Bioquell Qube provides the aseptic area you need to keep your research or production on track.
WHITE PAPERS AND CASE STUDIES
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ARMA 2005 Show Highlights Refined Solutions For Records Managers The message to attendees of this year's ARMA show was to engineer an easy transition from paper-based files to electronic records management, supported with a clear and calculated plan. ARMA provided me a chance to sit down and talk with ECM vendors about the special offerings they had for solving companies' records management needs. Check out some of news and highlights from the manufacturers and software providers that were at the show.
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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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TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
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PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
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The Next Leap In Pharma Manufacturing
Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.
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Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant
Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.
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Demanding More From AI Governance In Drug Safety
Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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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.
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Replacing A Paper-Based GMP System With An Electronic Monitoring System
As a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics' sought to replace an its paper-based GMP record system and manual process with an electronic monitoring system.
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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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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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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
NEWS
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New GARDCO RTM Digital Micrometer7/1/2025
Paul N. Gardner USA (GARDCO) – worldwide distributors, producers, and designers of quality physical and inspection instruments for the paint, coatings, and related industries–announces its new offering the new RTM Digital Micrometer with the comprehensive RT Kit option.
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Paylocity Advances One Unified HCM And Finance Platform With Launch Of Integrated Spend Management Solution7/22/2025
Paylocity, a leading provider of cloud-based HR, payroll and spend management solutions, today announced the launch of Paylocity for Finance, a strategic expansion of its modern workforce platform into the Office of the CFO.
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Singota Solutions Expands European Footprint To 3 Sites, Adds New State-Of-The-Art Facility In Balerna, Switzerland3/25/2025
Singota Solutions, a trusted partner for pharmaceutical development and cGMP sterile drug product manufacturing as well as supply chain services, announces the opening of its new facility in Balerna, Switzerland.
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Anritsu Supports EU Market Expansion By Ensuring Safety And Compliance Of 5G Wireless Devices10/21/2025
Anritsu Corporation has enhanced the functions of its New Radio RF Conformance Test System ME7873NR to support 5G wireless device conformance tests and compliance with the ETSI*1 EN 301 908-25 standard under the European Radio Equipment Directive (RED).
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SignWell Launches NOM-151 Compliant E-Signatures In Mexico12/9/2025
Businesses across Mexico now have a more straightforward, more affordable way to sign documents online legally. SignWell, a leading e-signature platform trusted by over 65,000 businesses globally, is now officially offering NOM-151-compliant electronic signatures, ensuring legal validity under Mexican regulations.