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Lack of data integrity is a key reason for breaching compliance. Although FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Any critical software must be supported by a properly conceived and performed validation project, normally following current GMPs. Learn how to develop and perform GMP validation with a Q&A with a co-author of 21 CFR Part 11.
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Osmolality testing as a quality control parameter is becoming more prevalent in the biomanufacturing sector of the clinical market. Keeping to specification is critical throughout the bioprocess workflow. Examine how osmolality testing can provide quick and easy identification of where certain solutions may be deviating from specification.
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Explore key considerations for early-stage clinical manufacturing under GMP regulations, including single-cell deposition methods, the importance of monoclonality assurance, consistency in the workflow, and the reduction of project timelines. Discover the best approach to tracking clones during their journey through the manufacturing process.
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Handheld pipettes, as well as automated liquid handling systems, are ubiquitous tools used in most life sciences laboratories. Here, we discuss the latest revisions to ISO 8655, the new ISO 23783 series of standards for automated liquid handing instruments, and what these standards mean for your laboratory.
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Robust And Reliable Single-Sample Micro-Osmometer
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At key points during process development and manufacturing, osmolality testing is critical. To have confidence that your therapeutic meets specifications to guarantee optimal critical quality attributes, you need robust and reliable quality control parameters. Discover a single-sample micro-osmometer you can depend on for process and quality control.
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Streamline Volume Verification With Confidence
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Without knowing the exact volume dispensed by handheld and automated liquid handlers, the accuracy of test results is unreliable, potentially leading to delays and cost overruns. Utilizing a multichannel verification system easily verifies the liquid delivery performance within minutes, preventing problems, bolstering laboratory productivity, and ensuring confidence in the integrity of data.
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GMP Certified Solution For Cell Therapy
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Optimize your workflow productivity and gain complete confidence in single cell seeding and clonality assurance. Examine a solution for high-efficiency single cell seeding with proprietary AI-driven cell recognition for the accurate detection of high-value cells that helps to de-risk regulatory submission with imaged-based proof of clonality.
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