BOSTON— June 24, 2013 – At the DIA 2013 49th Annual Meeting, Paragon Solutions, an advisory consulting and systems integration firm, and Microsoft Corporation today announced the release of an updated version of their well-accepted, collaborative whitepaper, “SharePoint Configuration Guidance for 21 CFR Part 11 Compliance.” The revision, entitled “SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance,” provides in-depth guidance to life sciences and healthcare organizations for meeting the challenges of FDA 21 CFR Part 11 compliance through the functionality and architecture of the latest release of Microsoft SharePoint, SharePoint 2013.
“SharePoint 2013 brings new capabilities and features that support compliance, including greater ability to configure technical capabilities and use much less custom code than the previous release,” said Les Jordan, chief technology strategist for Microsoft. “The paper demonstrates that the Microsoft SharePoint 2013 platform, in combination with Paragon Solutions’ and Microsoft’s industry expertise, can provide pharmaceutical firms with a more secure, compliant and collaborative solution to meet their information management and regulatory needs.”
“SharePoint is a key technology being used within life sciences and healthcare organizations,” said Jim Kane, director of collaboration and knowledge management for Paragon Solutions. “For day-to-day business across R&D and clinical organizations, compliance is a key issue. Being assured that SharePoint can be an enabling tool is extremely important. The assurance that compliance needs are met allows teams to expand their use of SharePoint across more business functions.”
The whitepaper not only uncovers advances in SharePoint 2013’s architecture that support compliance, it also establishes use cases for compliance with detailed configurations. In addition, the paper addresses the mapping between 21 CFR Part 11 and the detailed configurations that support each individual line of the regulation.
“Working with Microsoft, we are improving how business teams can use SharePoint in the workplace to address compliance, productivity and knowledge creation and management,” said Kane. “Paragon’s efforts illustrate how SharePoint 2013 is a power enabling tool in these areas, and supports Microsoft’s vision for how SharePoint is to be leveraged in the workplace.”
Along with providing life sciences industry expertise, Paragon developed the demonstration system, SharePoint configurations, workflows and sample source code for the whitepaper. Full details are outlined in the paper.
The whitepaper may be downloaded at the following link: SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.
Paragon works with businesses that are focused in a few key industries—communications, financial services, healthcare, insurance and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management and Information Insight.
For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582.