INSIGHTS ON QUALITY CONTROL
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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Inline Checkweighing Of Packaged Products In Manufacturing
Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.
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Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences
Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.
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How To Double Up With A CDMO To Reduce Risk12/12/2025
Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.
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Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance7/28/2025
Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
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Accelerate Your R&D And QC With These 3 Key Analysis Methods5/4/2024
Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.
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Regulatory Compliance And Advanced Solutions For Aseptic Environmental Monitoring1/29/2026
Modern aseptic monitoring requires a shift from periodic checks to risk-based strategies. Learn how to integrate particle and environmental data to meet Annex 1 standards and ensure patient safety.
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Delving Into Gene Expression Data Analysis And Experimental Reproducibility3/5/2026
Scientific reproducibility is essential for credible research. Learn to navigate standardized frameworks, refine normalization techniques, and ensure your data remains transparent and verifiable.
QUALITY CONTROL SOLUTIONS
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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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See how modern metal detection improves sensitivity, smart system designs, and tailored inspection technologies to strengthen quality control across food and pharmaceutical production.
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Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
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Pharmaceutical companies face cost, complexity, and speed pressures. Inspection solutions support quality and compliance with fill detection, weighing, foreign body detection, and label verification.
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Performing endotoxin testing? Trust your data with a Monocyte Activation Test that mimics the human immune reaction and detects both endotoxins and non-endotoxin pyrogens.