INSIGHTS ON REGULATORY COMPLIANCE
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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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Process Validation For Pharmaceutical Manufacturers
Manufacturers must validate their processes to meet FDA standards and protect consumer safety. Explore how process validation ensures consistent product quality and is a cornerstone of compliance.
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OEE And Product Inspection
Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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The Future Of Compliance, Efficiency, And Data Integrity
Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.
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State Of Validation Report 202412/17/2024
Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.
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Digitalizing Pharma Control Strategies: A Roadmap1/24/2025
Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Advanced Aseptic Filling Assembly Helium Integrity Testing10/15/2025
Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.
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Selecting The Best Deterministic Method For Your CCIT Project3/31/2025
Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.
REGULATORY COMPLIANCE SOLUTIONS
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Understand how to confidently meet GxP compliance in the life sciences. Explore a framework encompassing people, processes, products, and services for regulatory adherence and data integrity.
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Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.
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Microarray scanners for one-fluor to multi-fluor applications
The GenePix® Microarray Systems are based on 25 years of expertise in low-noise signal amplification and optical design. The systems can handle any slide-based microarray study, from small one- or two-fluor applications to multiple-fluor high-throughput projects requiring automated sample handling and secure enterprise-wide data management and analysis. All GenePix scanners include one license of GenePix Pro Image Acquisition and Analysis Software, the benchmark tool for the acquisition and analysis of microarray images.
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Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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Learn how harnessing a CDMO’s extensive knowledge and skills in dealing with controlled substances can help you advance your innovative psychedelic therapeutic safely and efficiently.