INSIGHTS ON QUALITY ASSURANCE
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![Scientists Work Together In Lab GettyImages-618725044]( "Early Development Considerations For NCE Success: Quality Systems")
Early Development Considerations For NCE Success: Quality SystemsLeveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.
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![GettyImages-1316723095-vial]( "What Does Annex 1 Mean For Cryovial Filling?")
What Does Annex 1 Mean For Cryovial Filling?New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.
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![GettyImages-1397047849-circuits-software-blue]( "How To Adopt CSA For Streamlined Computer System Validation")
How To Adopt CSA For Streamlined Computer System ValidationDiscover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.
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![Drug approvals]( "FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers")
FDA Product Recalls: A Wake-Up Call For Life Sciences ManufacturersDiscover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.
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Freeze Drying Process Development7/8/2025
Discover how a moisture mapping study using non-destructive headspace analysis enhances freeze-drying efficiency, optimizes cycle performance, and ensures precise control of residual moisture in vials.
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Drive Innovation With Validation 4.07/1/2025
Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.
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The Impact Of The FDA's New CSA Draft Guideline2/24/2025
Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.
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Cambrex Scientist Spotlight: Daniel Kirschner1/29/2025
With a Ph.D. in bioanalytical chemistry from the University of Alaska Fairbanks, Kirschner brings nearly 15 years of experience in pharmaceutical development across biotech and CDMO sectors.
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A Powerful Non-Destructive Tool For Tablet Characterization10/6/2025
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
QUALITY ASSURANCE SOLUTIONS
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![Lab GettyImages-1354171893]( "Biologics Quality Control: A Critical Component Of Development And Production")
Quality control is a critical component for ensuring safety, efficacy, and consistency in the development and production of biologics. This comprehensive list of strategies, techniques, workflows, and best-in-class products for developing biopharmaceuticals can help you navigate the complexities of biologics and simplify the manufacturing process. Improve your quality control procedures and optimize your biologics production process with tools and expertise relied upon by researchers worldwide.
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![Tulip Image 2]( "Manufacture High-Quality Products With Streamlined Compliance")
Manufacture high-quality products with streamlined compliance.
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![Thermo3]( "Sensors For Superior Process Control")
Thermo Fisher Scientific offers single-use and reusable sensors for the measurement of pH, DO, biomass, and headspace pressure along with The Thermo Scientific™ TruSens™ transmitter blade which is a combined technology designed to monitor all conventional pH and DO sensors.
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![Audit and inspection-iStock-1205235181]( "Corrective Action Preventive Action (CAPA) Software For Life Sciences")
Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
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![GettyImages-1597039529-coding-software-gears-phone]( "Software And Server Upgrade For Your Bioprocess System")
Consider the critical role of your XDR system. Discover why outdated hardware or an unsupported OS limits performance and security, which risks extensive downtime.
