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Gxp Computerized System: A Risk Based Approach
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| Author:
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SWATHI K.C, BALAMURALIDHARA V, M P VENKATESH, H V GANGADHARAPPA
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| Abstract:
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A Risk-Based Approach to Compliant GxP Computerized Systems gives practical industry guidance means to accomplish agreeable mechanized frameworks that are fit for proposed use in an efficient and effective manner, and furthermore attempted the regulatory and industry initiatives. GxP stands to Good practice and the "x" in GxP is a various field’s viz manufacturing, clinical, laboratory, Food, agriculture and laboratory etc. This aims to Regulated client ought to guarantee that the product and framework have been created to best designing practices in a quality assured way and discussing suppliers, software developers, quality management, system security, backup for computerized system to managing GxP Regulated systems and providing a cost effective framework of Good practices. Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidance has distributed direction on Great Practices for Computerized Systems in GxP Environments. In our studies highlighting GxP regulation compliance and Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidance helping in meeting all applicable regulatory requirements for pharmaceutical and associated life-sciences like agriculture, fisheries, biochemistry, biotechnology etc and gives knowledge about risk of the board to achieve Good practice in GxP environments.
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| Keyword:
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Computerized system, GxP (Good practice), Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidance
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.056
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| Download:
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Request For Article
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