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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorMiranda Narváez, Hiramdie
dc.date.accessioned2020-09-16T14:55:59Z
dc.date.available2020-09-16T14:55:59Z
dc.date.issued2016
dc.identifier.citationMiranda Narváez, H. (2016). CSV program implementation using a risk based approach to align ICH with GAMP [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/592
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractit has been 29 years when Process Validation was created. Since then there has been a lot of creations of different types of validations. During the years there have been a lot of improvements in every validation process. Different kind of process has been created to support validations. Quality is an important factor in any process nowadays. In this project we want to align a Quality Risk Management process like ICH Q9 with GAMP5 Computerized Systems Validation process. A DMAIC problem solving method was used to identify gaps between processes and provide a clear view to resolve the problems.in conclusion the best way to align these processes is to begin with a full risk assessment, risk control and continue with the GAMP5 process. Key Terms - Computer Systems Validation, GAMP5, ICH Q9, Quality Risk Management, Risk Assessment.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesWinter-2016;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPharmaceutical industry--Data processing
dc.subject.lcshPharmaceutical industry--Quality control--Standards
dc.subject.lcshPharmaceutical technology--Automation--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleCSV Program Implementation using a Risk Based Approach to align ICH with GAMP5en_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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