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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig3 CaoProcess2018 6-5.png|240px]]</div>
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'''"[[Journal:A systematic framework for data management and integration in a continuous pharmaceutical manufacturing processing line|A systematic framework for data management and integration in a continuous pharmaceutical manufacturing processing line]]"'''
'''"[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study]]"'''


As the pharmaceutical industry seeks more efficient methods for the production of higher value therapeutics, the associated [[data analysis]], [[data visualization]], and predictive modeling require dependable data origination, management, transfer, and integration. As a result, the management and integration of data in a consistent, organized, and reliable manner is a big challenge for the pharmaceutical industry. In this work, an ontological [[information]] infrastructure is developed to integrate data within manufacturing plants and analytical [[Laboratory|laboratories]]. The ANSI/ISA-88 batch control standard has been adapted in this study to deliver a well-defined data structure that will improve the data communication inside the system architecture for continuous processing. All the detailed information of the lab-based experiment and process manufacturing—including equipment, samples, and parameters—are documented in the recipe. This recipe model is implemented into a process control system (PCS), data historian, and [[electronic laboratory notebook]] (ELN). ('''[[Journal:A systematic framework for data management and integration in a continuous pharmaceutical manufacturing processing line|Full article...]]''')<br />
For the release of precise and accurate reports of [[Medical test|routine tests]], its necessary to follow a proper [[quality management system]] (QMS) in the [[clinical laboratory]]. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the [[laboratory]] testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory [[analyte]] by Six Sigma analysis and to plan and chart out a better, customized [[quality control]] (QC) plan for each analyte, according to its own sigma value ... ('''[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Full article...]]''')<br />
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Revision as of 16:52, 29 April 2024

Fig1 Karaattuthazhathu NatJLabMed23 12-2.png

"Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study"

For the release of precise and accurate reports of routine tests, its necessary to follow a proper quality management system (QMS) in the clinical laboratory. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the laboratory testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory analyte by Six Sigma analysis and to plan and chart out a better, customized quality control (QC) plan for each analyte, according to its own sigma value ... (Full article...)
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