INSIGHTS ON REGULATORY COMPLIANCE
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![Measuring And Monitoring Environmental Surface Residues]( "Measuring And Monitoring Environmental Surface Residues")
Measuring And Monitoring Environmental Surface ResiduesExplore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.
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![GettyImages-1173376974 cleanroom, disinfection]( "The Ex-Regulator's View On Small Surface Contamination Control")
The Ex-Regulator's View On Small Surface Contamination ControlEffective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety.
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![Path Toward Regulatory Compliance And Data Integrity With Microbial Testing]( "A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation")
A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems ValidationLearn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.
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![GettyImages-1087219526-scientist-computer-screen-compliance-sterilization]( "How To Choose The Right Bowie-Dick Test Pack For Your Steam Sterilizer")
How To Choose The Right Bowie-Dick Test Pack For Your Steam SterilizerBowie-Dick testing is essential for compliance, but the choice between disposable and reusable systems impacts cost, waste, and efficiency. Learn how to balance sustainability with sterility assurance.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis12/9/2024
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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Uncovering Blind Spots In Environmental Monitoring6/19/2025
Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.
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The Benefits Of Low Endotoxin Products6/16/2025
Minimizing endotoxin contamination is vital in pharmaceutical manufacturing to protect patients from harmful reactions. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.
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Navigating Regulatory Shifts: EU GMP Annex 1 And USP 3825/20/2025
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
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The FDA Modernization Act is Signed Into Law. Now What?4/22/2024
Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.
REGULATORY COMPLIANCE SOLUTIONS
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![Genedata Expressionist]( "Data Processing Across Instruments, Teams, And Sites")
Streamline mass spectrometry workflows with automated, harmonized data processing that delivers faster, more consistent results. Discover how you can reduce costs and improve efficiency.
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![PO 3 - GCApp_Stereo Microscope (person with blue coat)]( "Minimizing Uncertainty Throughout The Development Lifecycle")
Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
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![files iStock-1277601366.jpg]( "Document Control Software For Life Sciences")
Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.
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![CRISPR]( "Cleanrooms And Equipment For CRISPR Drug Manufacturing")
Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward
Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.
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![Genedata Bioprocess]( "Accelerate The Development Of Your Biotherapeutic Drugs")
Accelerate biotherapeutic development with a platform that integrates data across CLD, USP, DSP, and analytics, which supports advanced technologies, ensures compliance, and streamlines workflows.
