\nNavigating life sciences\u2019 compliance waters is challenging enough, and is even more
\ncomplicated for geographically dispersed companies. Medicines360, a nonprofit company,
\nwanted to improve control over its regulated documents, and allow easy sharing of information
\nfor efficient collaboration among employees in remote locations. Just in time for the launch of
\nits first product, the company solved its content management challenge with innovative cloud
\ntechnology from Veeva Systems.\n<\/p>\n
\nMedicines360 is an innovative, global nonprofit, women\u2019s health pharmaceutical company with a mission of
\nexpanding access to quality medicines, regardless of socioeconomics, insurance coverage, or geographic
\nlocation. The U.S. Food and Drug Administration (FDA) recently approved Medicines360\u2019s Liletta™
\n(levonorgestrel), a hormonal intrauterine device (IUD). Leveraging a cloud-based, advanced content management
\ntechnology to efficiently handle the demands of launching a new product, Medicines360 is now ramping up
\ncommercialization of its new product.\n<\/p>\n
\nMedicines360 relies heavily on geographically dispersed teams and partners. With only email, file share, and a
\npaperbased system, it was challenging to control and securely share regulated content. It was also not feasible
\nfor remote employees or contractors to come into the office when they needed to refer to a standard operating
\nprocedure (SOP) or other regulated document.\n<\/p>\n
\nMedicines360 was also moving beyond research and development to launch and commercialize its first product.
\nExisting processes for developing, reviewing, approving, and tracking training of controlled documents was
\ncomplex and inefficient. Without a single document management system that was easily accessible from
\nanywhere, the company did not have a consistent or efficient way to distribute controlled content and track
\nSOP training to ensure compliance.\n<\/p>\n
\n“I\u2019ve implemented many innovative systems to replace cumbersome manual processes
\nor poorly designed systems. Veeva QualityDocs is hands-down the best, and
\ndramatically improves the document control processes at Medicines360.”
\nKevin Loftus, QA Manager, Medicines360<\/span>\n<\/p><\/blockquote>\n\n\u201cAs a pharmaceutical company with employees around the globe, we needed to access, review, approve, and
\nsecurely distribute SOPs and other controlled documents from anywhere,\u201d explained Kevin Loftus, quality
\nassurance manager at Medicines360.\n<\/p>\n\nUltimately, these challenges and regulatory requirements for electronic records and electronic signatures
\n(ERES) provided the catalyst for Medicines360 to look for an electronic document management system.\n<\/p>\nSearching for a Compliance Ready Solution<\/h2>\n
\nMedicines360 evaluated a number of solutions, and only Veeva QualityDocs met all the requirements:
\nintuitive user interface, robust audit trail, compliant electronic signatures, and validation support. Based on
\npast experiences with legacy systems, the team also knew they wanted a cloud-based document management
\napplication. On premise systems require considerable IT support and infrastructure, and hosted solutions only
\nshift the physical location of servers, carrying the same high financial burden.\n<\/p>\n\nAs an organization with mobile users and partners around the globe, Medicines360 needed a solution that
\ndid not require extensive user training or IT maintenance. \u201cA complicated interface would have taken several
\nmonths to configure, validate, and train all the users. We simply didn\u2019t have the time or the people to support
\nthat,\u201d said Loftus.\n<\/p>\n\nVeeva QualityDocs is intuitive and accessible from any major web browser, allowing users to easily learn and
\naccess the application from anywhere \u2013 minimizing training and ongoing support. With Veeva QualityDocs\u2019
\ntrue multitenant cloud and validation-ready software updates, Medicines360 is always on the latest release.
\nThe ability to seamlessly view PDF documents also removed the infrastructure complexity and connection
\nchallenges experienced with other applications. Free from system maintenance, Medicines360 is focusing
\nresources on research and development, and commercialization of the new product.\n<\/p>\n\n\u201cI knew we had to move to the cloud to optimize our resources and still deploy a world-class solution,\u201d noted
\nLoftus. \u201cWhen we started our search, I wasn\u2019t sure we could find a solution
\nthat would not require significant customization. Veeva\u2019s specialized functionality gives us the features we need
\nin an interface that\u2019s easy to use for end users and administrators. Validation-ready, Veeva QualityDocs saves us
\nconsiderable time and resources.\u201d\n<\/p>\n\nVeeva Quality\u2019s cross-browser, cross-platform functionality also allows Medicines360 to easily collaborate with different
\nfunctional areas and share best practices in real time. Veeva\u2019s complete suite of fully interoperable content
\nmanagement applications gives the company compliant, efficient document processes across marketing,
\nclinical, quality, and regulatory teams as it transitions from R&D-only to also supporting commercial operations.\n<\/p>\nShort Implementation Time<\/h2>\n
\nMedicines360 implemented Veeva QualityDocs dramatically faster than expected \u2013 largely due to native life
\nsciencesspecific functionality including preconfigured quality workflows and document taxonomy. Veeva\u2019s
\nunderstanding of the regulated environment is also reflected in the validation documentation that is available
\nwith each release, and electronic signatures and audit trails that meet 21 CFR Part 11 requirements – making
\ncompliance easier for organizations.\n<\/p>\n\nThe team made only a few, simple terminology changes to map Veeva QualityDocs\u2019 document types names and
\nfields with Medicines360\u2019s nomenclature. \u201cAs a small company, we thought moving to a new system would be
\na year-long project,\u201d remarked Loftus. \u201cInstead it was only four weeks to get the system up and running with our
\nconfiguration – including workflows. It took only another four weeks to have 80% of our quality management
\ndocuments fully migrated and managed exclusively in Vault QualityDocs. The flexibility of the application and
\nthe support of the Veeva project team is absolutely extraordinary in my experience.\u201d\n<\/p>\n\nMany users were also able to pick up the system with very little formal training \u2013 a key benefit for a small, virtual
\ncompany that is now on call for unannounced inspections. \u201cVeeva Quality is intuitive and user-friendly \u2013 as easy to use
\nas Amazon,\u201d added Loftus.\n<\/p>\nMaking Compliance Easier and Increasing Operational Efficiency<\/h2>\n
\nGoing paperless has proven to be a positive milestone for Medicines360, according to Loftus. Since
\nimplementing Veeva QualityDocs, the company has seen significant operational improvement, including:\n<\/p>\nIncreased Efficiency<\/h3>\n
\nGone are the days of shuffling folders from reviewer to reviewer. Managing document and workflows
\nelectronically with Veeva QualityDocs keeps documents visible, no matter where the content is in its lifecycle,
\nand maintains strict version control, regardless of who has access or makes changes. Authorized users can
\nquickly search across all documents to find what they need and easily share content, greatly improving
\ncollaboration and task execution.\n<\/p>\nImproved Productivity<\/h3>\n
\nHaving access to critical content on any device, anywhere, and at any time leads to more productive employees.
\nUsers can now complete \u2018Read & Understood\u2019 tasks for SOPs and review documents on a desktop or mobile
\ndevice thanks to Veeva. \u201cIn terms of managing our document lifecycle \u2013 taking documents from draft, through
\nreview, revision, approval, issuance, and training, we have been more productive in the last six months than the
\nentire year before that,\u201d stated Loftus. A user-friendly interface and intuitive viewing options, such as presenting
\nmetadata and the document on the same screen, also greatly improve productivity.\n<\/p>\nEasier Training<\/h3>\n
\nBefore Veeva QualityDocs, Medicines360 maintained large training binders, which were updated manually when a
\ntraining session was completed, making it difficult to enforce and track training. Now, managers can easily
\nmonitor training progress and rectify any problems quickly. Reminders on re-training are also built-in to ensure
\nusers are always up to date on SOPs.\n<\/p>\nFaster Reporting<\/h3>\n
\nWith Veeva QualityDocs\u2019 extensive reporting capabilities users can easily gain visibility into compliance status,
\nsuch as which users or departments have outstanding \u2018Read & Understood\u2019 tasks. The Vault dashboards keep
\nreports at users\u2019 fingertips and make it easy to run reports on dozens of different metrics.\n<\/p>\nExpedited Inspections<\/h3>\n
\nVault\u2019s organized and searchable document repository, electronic signatures, and detailed audit trails facilitate
\ninspection-readiness at all times. Users can easily find requested documents or demonstrate compliance with
\n21 CFR Part 11 compliant e-signatures and audit trails.\n<\/p>\nExpanding to Clinical and Regulatory Content<\/h2>\n
\nAs Medicines360 looks toward the future, the team expects additional commercialization and submission
\nopportunities involving many different stakeholders. Veeva Quality will help Medicines360 manage and control the
\nresulting documentation efficiently and compliantly. Already, the company is planning to expand Vault usage to
\ninclude all clinical and regulatory content. With the flexibility and scalability of Veeva, Medicines360 is always
\npoised for growth.<\/p>\n","protected":false},"excerpt":{"rendered":"Just in time for the launch of its first product, the company solved its content management challenge with innovative cloud technology from Veeva Systems.<\/p>\n","protected":false},"featured_media":62660,"parent":0,"template":"","product-link-list":[],"class_list":["post-97349","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/97349"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":0,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/97349\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62660"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=97349"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=97349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}