INSIGHTS ON REGULATORY COMPLIANCE
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![Sefia Platform Spotlight Features Designed To Reduce Batch Failure Risk]( "Reduce Batch Failure Risk With An Innovative Platform")
Reduce Batch Failure Risk With An Innovative PlatformEnhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.
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![Compliance GettyImages-1212446127]( "Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing")
Compressed Gas Contamination: Guidelines For Control In Aseptic ManufacturingExplore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.
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![millipore sigma managing nitrite impurities]( "Managing Nitrite Impurities: Supplier-Manufacturer View")
Managing Nitrite Impurities: Supplier-Manufacturer ViewExamine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.
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![GettyImages-1214111358 Team Of Professionals Working Together On Computer]( "State Of Validation Report 2024")
State Of Validation Report 2024Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.
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Efficient Pathways: The Regulatory Edge Of New Zealand For Pharmaceutical Development7/29/2024
By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.
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Stories From The Field: Supporting Critical Steps In Fill And Finish8/7/2025
Explore the critical final step in drug development—formulation and filling—and discover expert strategies that can help streamline operations, reduce risk, and enhance efficiency.
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FDA Recall Prevention: Save Time, Money, And Reputation10/8/2024
FDA product recalls pose significant challenges for life sciences companies. Avoid recalls with these actionable steps to mitigate risk, ensure compliance, and safeguard your organization's reputation.
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Correlating Stopper Height To Container Closure Integrity11/21/2023
Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.
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How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance9/26/2025
Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1180547354 digital data]( "MasterControl Change Control™")
Explore a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They're designed to allow “continuous validation” for FDA-regulated companies.
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![Veya™]( "Veya™: Effortless Automation")
Automate research and clinical workflows with intuitive setup, fewer errors, and optimized instrument use that supports regulated environments and delivers personalized service.
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![GettyImages-2178732166-scientists-screen-imaging-microscope-laboratory]( "Application Guide For Multimode Readers")
Explore imaging, fluorescence, and luminescence-based techniques for cell analysis, viability, and gene expression, as well as how multimode readers streamline workflows and enhance data quality.
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![GettyImages-1131583289-scientists-laboratory-monitor-screen-computer]( "Enhanced Intelligent Batch Records")
Aizon Execute V2.1.0 is here — and it’s packed with powerful new capabilities designed to make digital batch execution even more flexible, efficient, and intelligent.
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![ViralVectors]( "Cleanrooms And Equipment For Viral Vector Drug Manufacturing")
Viral vector manufacturing: key to successful gene therapy
Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.
