dc.rights.license | All rights reserved | en_US |
dc.contributor.advisor | González Miranda, Carlos J. | |
dc.contributor.author | Figueroa Pabón, Elizabeth | |
dc.date.accessioned | 2020-06-23T13:49:21Z | |
dc.date.available | 2020-06-23T13:49:21Z | |
dc.date.issued | 2019 | |
dc.identifier.citation | Figueroa Pabón, E. (2019). Improving the custom-built applications computerized system validation lifecycle for a medical device company [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico. | en_US |
dc.identifier.uri | http://hdl.handle.net/20.500.12475/170 | |
dc.description | Design Project Article for the Graduate Programs at Polytechnic University of Puerto Rico | en_US |
dc.description.abstract | This research project was focused in the
improvement of the Custom-Built Applications
Computerized System Validation Lifecycle for a
Medical Device Company. A Computerized System
Validation is the process of documenting the
deliverables of a system with the purpose of showing
fulfillment of the requirements. The Custom-Built
Applications Computerized System Validation
Lifecycle was improved by reducing the Production
Lead Time from 502.66 days to 307.09 days. This
improvement reduced the timeline by 195.67 days.
This represents a reduction of 39% of the waste.
Additionally, the amount of forms that are generated
through the lifecycle were reduced from 26 forms to
13. The waste in form development was reduced by
50%. In the present, the Custom-Built Applications
Computerized System Validation Lifecycle cost is
$46,256.00. As a result, these improvements
represent a saving for the Medical Device Company
of $17,976.00 per each Custom-Built Applications
Computerized System Validation Lifecycle. This
represents 39% of cost reduction.
Key Terms ⎯ Computerized System Validation,
Custom-Built Applications, Medical Device,
Software Tool Regulations. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Polytechnic University of Puerto Rico | en_US |
dc.relation.ispartof | Manufacturing Engineering | |
dc.relation.ispartofseries | Fall-2019 | |
dc.relation.haspart | San Juan Campus | en_US |
dc.subject.lcsh | Medical instruments and apparatus | |
dc.subject.lcsh | Six sigma (Quality control standard) | |
dc.subject.lcsh | Expert systems (Computer science)--Validation | |
dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Research | |
dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Posters | |
dc.title | Improving the custom-built applications computerized system validation lifecycle for a medical device company | en_US |
dc.type | Article | en_US |
dc.rights.holder | Polytechnic University of Puerto Rico, Graduate School | en_US |