INSIGHTS ON REGULATORY COMPLIANCE
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Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2
Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.
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Leachables Method Development, Validation And Relevant ICH References
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Ensure Consistency Across Batches With A Powerful Tool
Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.
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Maximizing ROI: Extracting Value From Analysis And Reporting
How can organizations establish the foundation for advanced analytics, AI and ML, in pursuit of a robust and adaptive lab of the future?
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Regulatory Considerations When Choosing Stem Cell Media10/31/2024
Watch to explore key considerations for researchers moving from academia to industry or expanding their operations.
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How Particle Counting Efficiency Affects Distribution Data6/24/2025
Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.
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Trends In Next-Generation Delivery Technologies11/22/2023
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
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A Blueprint For Avoiding FDA Recalls10/9/2024
Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.
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The CHO Toolkit: Flexible Solutions For Complex Molecules9/11/2025
A modular cell line development platform helps overcome biologic complexity. Learn how flexibility and expert support drive success from early development through commercial manufacturing.
REGULATORY COMPLIANCE SOLUTIONS
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Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
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The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.
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Discover how microbial testing services can streamline QC workflows, ensure regulatory compliance, and reduce resource strain with tailored equipment and expert support.
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The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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The journey of a GLP-1 receptor agonist (GLP-1 RA) molecule is complex.