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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorSepúlveda Figueroa, Héctor
dc.date.accessioned2020-09-17T12:37:47Z
dc.date.available2020-09-17T12:37:47Z
dc.date.issued2014
dc.identifier.citationSepúlveda Figueroa, H. (2014). Quality risk management strategies for computer systems validation [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/717
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractQuality Risk Management is something that has been gaining attention in the regulated industry because it is listed as regulation in various regulatory agencies such as FDA, ICH, ISO, ISPE and other involved regulatory agencies, but all with the same goal of improving the and manufacturing quality of a product manufactured for the patient to be administered. From this part briefly assess how QRM strategy works by Good Manufacturing Practices, and regulatory requirements and associated guidance documents, making certain methodology on QRM to CSV is presented. We must take into account that there is no fixed for all situations that arise in a given time methodology. The competent professional is the best person to select which type of methodology will do the QRM to be adjusted to the problem presented in the areas related to computer systems. In this article we present how we can achieve risk reduction through QRM in CSV. Key Terms - Computer Systems Validation, Quality Risk Management, Risk Reduction, Strategies.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesWinter-2014;
dc.relation.haspartSan Juanen_US
dc.subject.lcshRisk management
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshPharmaceutical industry--Management
dc.subject.lcshHealth facilities--Risk management
dc.subject.lcshPharmaceutical industry--Data processing
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleQuality Risk Management Strategies for Computer Systems Validationen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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