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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorColón Nazario, Alexis
dc.date.accessioned2020-06-23T19:32:41Z
dc.date.available2020-06-23T19:32:41Z
dc.date.issued2018
dc.identifier.citationColón Nazario, A. (2018). Computer system validation CSV in data integrity implementation strategies for pharmaceutical industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/191
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractComputer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). Due to the rise in cGMP violations involving data integrity during regulatory inspections, there have been issuances of many warning letter, import alerts and consent decrees. Electronic signature and record-keeping requirements as mentioned in 21 CFR Part 11 and apply to certain records, subject to records requirements set forth in Agency regulations, including parts 210, 211 and 212. Further, regulations for Computer System Validation CSV in data integrity issues occur mostly in quality laboratories and production areas and the causes vary due to personnel, equipment and management. The implementation of regulatory guidelines and standard operating procedures for data integrity, regular internal audits or surveillances and training will pave way for pharmaceutical industries to maintain Computer System Validation CSV in data integrity flawlessly. Key Terms - ALCOA, cGMP Violations, CSV, Electronic Signature, Regulations, Training, Warning Lettersen_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering
dc.relation.ispartofseriesSpring-2018
dc.relation.haspartSan Juan Campusen_US
dc.subject.lcshPharmaceutical industry--Quality controlen_US
dc.subject.lcshPharmaceutical industry--Data processingen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleComputer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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