\nFounded in 2015, Arcus Biosciences is rapidly evolving into a fully integrated biopharmaceutical
\ncompany focused on cancer therapies. To ready the company for growth and regulatory
\ninspections, Arcus transitioned from an uncontrolled environment of emails and SharePoint sites
\nto a validated RIM system. The move addressed multiple deficiencies, including a lack of version
\ncontrol, distribution control, audit trails, and standard business processes.\n<\/p>\n
\nArcus selected Veeva as its technology partner because
\nthe unified Vault Platform met its needs across regulatory,
\nquality, clinical, and medical affairs.\n<\/p>\n
\nWithin regulatory, Arcus deployed Veeva Submissions and Veeva
\nSubmissions Archive to bring together documents and data.
\nThe implementation involved a lot of upfront preparation and
\nuser participation since the company was essentially starting
\nfrom scratch. The project team led six critical workstreams to
\nensure a successful rollout: IT infrastructure, business process, system configuration, training, data migration, and
\nvalidation. The project took just three months from kick-off to go-live, an aggressive timeline that was made even more
\nchallenging by COVID-19.\n<\/p>\n
\nArcus launched Veeva RIM in June 2020 with a robust training program that eased the transition for more than 60 users.
\nThe company now has a single, secure authoritative source for submissions content. Regulatory staff work more efficiently
\nand follow standard, auditable processes from submission planning through approval.\n<\/p>\n
\nArcus\u2019s RIM journey is ongoing. The company has shifted its focus to post-launch activities, including training for infrequent
\nusers and new hires. The company also hosts a monthly user forum to address questions, resolve issues, and solicit ideas
\nfor system enhancements. Arcus will continue to evolve its RIM solution by acting on this feedback.\n<\/p>\n
“The implementation is the beginning of the conversation with your customers, it\u2019s not the end.”
\n\u2013 Lisa Owens, Senior Director of Regulatory Operations at Arcus Biosciences<\/span>\n<\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"To ready the company for growth and regulatory inspections, Arcus transitioned from an uncontrolled environment of emails and SharePoint sites to a validated RIM system.<\/p>\n","protected":false},"featured_media":62377,"parent":0,"template":"","product-link-list":[1411,1418,1437,1438,1440,1455],"class_list":["post-65061","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-ctms","product-link-list-veeva-etmf","product-link-list-veeva-promomats","product-link-list-veeva-qms","product-link-list-veeva-qualitydocs","product-link-list-veeva-training"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t