{"id":19160,"date":"2021-10-11T11:45:00","date_gmt":"2021-10-11T11:45:00","guid":{"rendered":"https:\/\/expleo.com\/global\/en\/?post_type=case-studies&p=19160"},"modified":"2023-08-25T12:22:29","modified_gmt":"2023-08-25T12:22:29","slug":"computerised-system-validation-for-facility-and-asset-management-digitalisation-program","status":"publish","type":"case-studies","link":"https:\/\/expleo.com\/global\/en\/case-studies\/computerised-system-validation-for-facility-and-asset-management-digitalisation-program\/","title":{"rendered":"Computerised system validation for facility and asset management digitalisation program"},"content":{"rendered":"\t\t
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Expleo is ensuring one of the leading pharmaceutical groups in the world\u2019s IT systems for facility & asset management (FAM) and other systems are validated and consistent to comply with health regulations worldwide.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Project background & Challenge\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Expleo has been working with a leading pharmaceutical group since 2008 on various IT systems projects. In 2021, this client asked us to provide validation lead experts to ensure their IT systems for FAM and other systems are, and remain, compliant with the FDA and other health authorities regulations throughout sites worldwide. The global FAM program started in our customer\u2019s main facility in Germany and will be rolled out worldwide to about 20 sites, with several facilities to be maintained.<\/p>

With geographical variations based on different regulations (depending on local health authorities), our customer wanted to ensure worldwide transformation of business processes and data from local systems into one global ERP system, with correct data migration from source systems to target systems.<\/p>

Raising awareness about the regulated patient-safety environment to all project members, as well as ensuring the digital facility & asset management system is compliant and does not fail inspections or external audits by health authorities and customers was key.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Solution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Working with external consultants and contractors fully integrated within various customer\u2019s teams and organisations to fulfill the project demands, Expleo\u2019s diverse skills and experience of complex project mangement means we can offer a full array of services, from validation leads to test coordination, quality control, data migration experts, creation and execution of risk and data integrity assessments, documentation reviews (for URS \/ FS \/ TC \/ SOP), etc. As experts in computerised system validation (CSV) we provide consulting for software validation according to pharmaceutical standards (GxP, GAMP5, FDA).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\r\n Outcome <\/h2>\r\n
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Digitalising and centralising facility & asset management can get more processes and systems implemented and reduce paper-based workflows. Expleo\u2019s deep knowledge of the internal customer processes in software development over the years is resulting in a uniform delivery of services and documents creation with continuity in the services and quality provided. Our validation leads ensure that the computerized systems get validated in time and on budget.<\/p>

\u00a0<\/p><\/span> <\/div>\r\n <\/div>\r\n\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tRead the full case study<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\tI have been working in IT from the very beginning as Developer, Tester and Manager for almost 27 years in the pharmaceutical industry. Applying my knowledge to this industry is challenging and rewarding. The client is satisfied with the work that my team and I are delivering, and after several years working for them, there are good opportunities to extend the contract.\t\t\t<\/p>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\tThomas Heimsath, Quality Assurance Manager, Expleo<\/cite>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/blockquote>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\r\n Transformation Consultancy <\/strong> <\/p>\r\n \r\n

\r\n Project Management Office<\/span> <\/h2>\r\n
\r\n Expleo fulfills the needs of production line managers with an end-to-End Tool Design and Manufacturing\u200b engineeering support that enables production of innovative and complex products<\/span> <\/div>\r\n \r\n
\r\n \r\n learn more <\/a>\r\n <\/div>\r\n\r\n <\/div>\r\n\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Expleo is ensuring one of the leading pharmaceutical groups in the world\u2019s IT systems for facility & asset management (FAM) and other systems are validated and consistent to comply with health regulations 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