Generis Knowledge Management Inc. today announced its partnership with DocShifter to provide industry-leading rendition handling as part of its CARA toolsuite. Together with the functionality in CARA, and the advanced content conversion abilities of DocShifter, the resulting application will provide complete compliance functionality for regulated content management use cases, especially Life Sciences. The solution will be 21 CFR Part 11 and GxP compliant, as well as offering the End to End RIM (Regulatory Information Management) functionality of CARA.
“There are various regulatory requirements that our clients face to provide content in a compliant set of formats, with the features and functionality of CARA on top”, said James Kelleher, CEO at Generis. “Our integration with DocShifter enables customers to ensure that content is managed to these requirements, with a wide range of integrations that CARA also offers to other applications specifically in the Life Sciences industry.”
With this new integration, Generis and DocShifter offer customers a tightly integrated solution. CARA provides customers an industry-leading, cost-effective and highly flexible user interface, either on premises or in the cloud; Generis’s customers include 8 of the top 10 largest Life Science companies as well as government and finance companies, and there are over 400,000 licensed users of Generis software products. CARA in particular not only provides a high degree of ergonomic and functional advantages, but comes with a set of Life Sciences solutions pre-packaged as accelerators or “RapidDeploy” options, including Submission / CTD, Electronic Trial Master File (eTMF), SOPs / Quality Management, and Change Control.
DocShifter allows customers to easily automate the generation of compliant output according to the different local regulatory authorities’ needs. Other uses include robotic form generation, correspondence management, tracking automation, and standardization for archiving.
Geert Van Peteghem, CEO at DocShifter states “The combined CARA and DocShifter solution can drastically speed up and simplify the process of generating compliant output. Our customers in Life Sciences are seeking an easy way to create submission ready PDFs, in accordance with the different local regulatory requirements”, adding that “the need for content conversion capabilities is growing: preparing content for archiving; and automating correspondence tracking processes being two such use cases. This partnership with Generis will allow us to streamline previously disjointed processes for our customers and maximize their investment with us.”
DocShifter was created in 2007 to respond to the need for easy and fast content conversion in highly regulated environments. Customers can be found worldwide in Life Sciences, Public Sector, Engineering, Banking & Insurance. The company is headquartered in Ghent, Belgium.
At DocShifter, we believe that relevant digital content should never become obsolete. Unstructured information needs to be kept in a readable and searchable format, for generations to come. In our fast-paced digital world, standards appear and disappear. Transforming all this digital content, in whatever shape or form is our goal. To ensure your information continues to provide value.
For more information about DocShifter, visit https://www.docshifter.com
About Generis Knowledge Management, Inc.
Generis has been providing leading-edge software for content management systems including Documentum, SharePoint, Alfresco and Oracle WebCenter since 1997. The company has more than 50 customers across industries from Federal Government, through Life Sciences and Engineering to Media, Publishing and Financial. The company is headquartered in Sarasota, FL, and has its principal development centers in Europe. Customers include 8 of the global top 10 Life Science companies, Federal and State governments, engineering and media companies.