\nFor over 70 years, Swiss-based Ferring Pharmaceuticals, one of the world\u2019s largest privately owned biopharmas, has built a strong reputation in reproductive medicine and maternal health, gastroenterology and urology. Recently, the company has gained a foothold in new innovative markets by strengthening its R&D efforts and investing in enabling technologies.\n<\/p>\n
\nIn order to scale innovation for the future, Ferring\u2019s leaders are focusing on digitization and standardization, and strengthening technical operations. Over the past few years, Ferring has standardized business applications globally and evaluated and implemented novel quality and manufacturing approaches that include electronic batch recordkeeping, process analytical technology, and continuous manufacturing to achieve these goals.\n<\/p>\n
\nFerring is also moving its quality GxP document management to the cloud by implementing Veeva QualityDocs. The project\u2019s main goal is to ensure data accuracy and compliance, but the effort will also help the quality team harmonize processes and data and establish clear governance, explains Racha, manager of GQA IT quality compliance and projects.\n<\/p>\n
\nBoth Racha and Fran\u00e7ois Xavier, associate director of GQA quality systems, envision having all of Ferring\u2019s quality systems on a single platform. \u201cWe need to be using standard processes at facilities around the world, and to be working from the same data,\u201d Racha explains.\n<\/p>\n
\nBefore implementing Veeva QualityDocs, Ferring\u2019s quality documents had existed in redundant files and in a number of different data formats within different EDMS programs and in disconnected MS SharePoint libraries. Users had to request access to individual files in order to get what they needed to complete their work, says Fran\u00e7ois Xavier.
\nIn addition, work processes typically varied by site. \u201cWe needed a transparent, harmonized system in which all documents would be openly accessible to anyone who needed them,\u201d says Racha.\n<\/p>\n
\nAdopting harmonized processes throughout its sites, labs, and offices, the team standardized all documentation on one set of data formats. It also eliminated a number of obsolete home grown systems and EDMS programs, and brought quality data into Veeva QualityDocs. To improve efficiencies, Ferring has implemented a number of special features in Veeva QualityDocs that have helped improve user experience and adoption, including collaborative authoring<\/a>, use of templates<\/a>, as well as process navigator<\/a> and enhanced periodic review<\/a>.\n<\/p>\n \nSo far, Racha says, the new system and approach have reduced the time it takes for quality team members to find data and documentation. Long-term, the application promises to make compliance easier. \u201cHaving one platform, one data, and one governance all improve compliance by providing extra checks,\u201d she explains.\n<\/p>\n \nUsers find Veeva QualityDocs easy to use, and improved system design has led to a significant reduction in user errors, Racha and Fran\u00e7ois Xavier agree. Currently, roughly 8,000 staffers at 67 of the company\u2019s global divisions use the application to manage over 20,000 documents for manufacturing, research, finance, human resources, and marketing. Soon, all business-critical business and GxP process documentation will be managed within Veeva QualityDocs.\n<\/p.\n\n\n \nEstablishing this foundation should simplify the next stage of unifying Ferring\u2019s quality systems, Fran\u00e7ois Xavier says.\n<\/p>\n \nAlthough the QualityDocs implementation is still at a relatively early stage, the results are \u201clike night and day\u201d when compared with those using previous platforms, Racha says.\u201cNow, not only do we have one standard process and way of working, the system is validated so we don\u2019t have to worry about compliance,\u201d she adds.\n<\/p>\n \nAs it completes its implementation of Veeva QualityDocs, Ferring\u2019s team has learned a number of lessons crucial to getting future technology implementations right the first time, says Racha. For one thing, the project reinforced the importance of understanding the data and ensuring its cleanliness and uniformity before migration. \nFran\u00e7ois Xavier and Racha advise companies to think long term. Harmonization is crucial, says Racha. \u201cBe sure to focus on the idea of having one database and one platform,\u201d adds Fran\u00e7ois Xavier.\n<\/p>\n \nCollaboration with Veeva has been very positive, says Racha. In addition, she says, when questions come up, Veeva partners \u201clisten and always have an answer.\u201d\n<\/p>\nLessons learned and implementation advice<\/h2>\n
\nInvesting in user training has also been crucial, says Fran\u00e7ois Xavier. But that is only the beginning, he notes. Moving from disconnected legacy systems to the cloud is a mindset shift. Investment in change management is important to help users adjust.\n<\/p>\n