{"content":[{"text":"Case Study","bbox":{"left":0.879472,"top":0.00661,"width":0.09706899999999996,"height":0.046085}},{"text":"Computer Software Validation for \n Multinational Pharmaceutical Company","bbox":{"left":0.238833,"top":0.067524,"width":0.5183130000000001,"height":0.12146900000000002}},{"text":"Challenge \n Pharmaceutical company \n acquires a European company \n and needs to expand in \n European market","bbox":{"left":0.082833,"top":0.254215,"width":0.20818599999999998,"height":0.19783699999999999}},{"text":"Solution \n Implement a validated ERP \n system to meet regulatory \n approval","bbox":{"left":0.413931,"top":0.254215,"width":0.18541499999999994,"height":0.16524399999999995}},{"text":"Outcome \n PharmaLex – powered by Arbour \n Group validates the software \n system while working with the \n implementation team","bbox":{"left":0.745764,"top":0.252635,"width":0.22559300000000004,"height":0.199417}},{"text":"•","bbox":{"left":0.025967,"top":0.490626,"width":0.004843,"height":0.027475000000000027}},{"text":"Executive management needed \n deployment of ERP system at the \n acquired European site to support the \n anticipated increase in business volume \n and complex supply chain model \n The pharmaceutical corporation needed \n computer software validation to meet US \n and EU regulatory requirements followed \n at other company locations \n Validation efforts necessitated remote \n support to work alongside implementation \n team","bbox":{"left":0.0448,"top":0.486452,"width":0.255087,"height":0.35977499999999996}},{"text":"•","bbox":{"left":0.344569,"top":0.490626,"width":0.004842999999999986,"height":0.027475000000000027}},{"text":"PharmaLex – powered by Arbour Group utilized \n remote consulting resources from its \n international testing facilities and worked with \n senior management and project team leaders \n to validate the enterprise system \n Validation deliverables included: Validation \n Plan, User Requirements, Product/Patient \n Safety Risk Assessment, Functional \n Specifications, Platform IQ Protocol, \n Application OQ Protocols, System PQ Protocol, \n Validation Trace Matrix, and Validation \n Summary Report","bbox":{"left":0.363403,"top":0.486452,"width":0.291201,"height":0.35977499999999996}},{"text":"•","bbox":{"left":0.688264,"top":0.490626,"width":0.004843000000000042,"height":0.027475000000000027}},{"text":"This successful computer software \n validation project was the first validation \n effort for this European site \n PharmaLex – powered by Arbour Group \n worked with client personnel to closely \n train and mentor local resources \n throughout the project for a successful \n validation delivery \n European site had a validated ERP that \n increased reliability, reduced risk, and \n was ready for European market \n expansion","bbox":{"left":0.707097,"top":0.486452,"width":0.24502599999999997,"height":0.35977499999999996}},{"text":"•","bbox":{"left":0.688264,"top":0.579515,"width":0.004843000000000042,"height":0.027475000000000027}},{"text":"•","bbox":{"left":0.025967,"top":0.638774,"width":0.004843,"height":0.027474}},{"text":"•","bbox":{"left":0.344569,"top":0.638774,"width":0.004842999999999986,"height":0.027474}},{"text":"•","bbox":{"left":0.688264,"top":0.727712,"width":0.004843000000000042,"height":0.027474}},{"text":"•","bbox":{"left":0.025967,"top":0.757352,"width":0.004843,"height":0.027474}}],"images_bbox":[{"left":0.685833,"top":0.298667,"width":0.051167,"height":0.090963},{"left":0.026333,"top":0.305778,"width":0.043333,"height":0.077037},{"left":0.354833,"top":0.290963,"width":0.051167,"height":0.106667},{"left":0.059,"top":0.954963,"width":0.139333,"height":0.044444}],"images_bbox_not_text_overlap":[{"left":0.685833,"top":0.298667,"width":0.051167,"height":0.090963},{"left":0.026333,"top":0.305778,"width":0.043333,"height":0.077037},{"left":0.354833,"top":0.290963,"width":0.051167,"height":0.106667},{"left":0.059,"top":0.954963,"width":0.139333,"height":0.044444}]}