CRANFORD, NJ — February 15, 2011 – Paragon Solutions, a business consulting and information technology services firm announced today the release of an in-depth whitepaper entitled, “SharePoint Configuration Guidance for 21 CFR Part 11 Compliance.” With a focus on the functionality and architecture of Microsoft SharePoint 2010 and its compliance enhancements, the paper is targeted to life sciences organizations challenged to meet industry regulations and specifically 21 CFR Part 11 compliance.
The whitepaper describes the features of SharePoint 2010 and demonstrates configuration methods for document and records compliance and a broad range of regulations, to drive toward 21 CFR Part 11, the federal guidelines on electronic records and electronic signatures for pharmaceutical firms or other FDA regulated industries in the United States. When combined with other Microsoft technologies, SharePoint 2010 can provide a system with the capability of enhancing 21 CFR Part 11 compliance, which in turn assists with records management procedures and helps to eliminate the costs associated with non-compliance of regulatory mandates.
“The FDA is routinely enforcing its records retention policies and procedures, which is driving pharmaceutical firms to seek content management systems and collaborative solutions that satisfy the requirements of these federal regulations,” says Les Jordan, chief technology strategist, Microsoft Life Sciences. “The paper demonstrates that the Microsoft SharePoint 2010 platform in combination with Paragon’s and Microsoft’s industry expertise can provide pharmaceutical firms a more secure, compliant, collaborative solution to meet their records management and regulatory needs.”
As a departure from previous whitepapers that address SharePoint and collaboration, the current whitepaper creates differentiation by addressing the overall SharePoint architecture needed to support compliance, and establishing use cases for compliance along 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.
“This whitepaper announcement marks the latest milestone in the ongoing collaborative work between our two companies,” says Ravi Shankar, Vice President for Life Sciences, Paragon Solutions. “For the last several years, Paragon has been implementing Microsoft technologies as part of its life sciences collaboration and content management solutions in a variety of areas like clinical investigator portals, structured protocol authoring, knowledge communities, and electronic trial master files,” Shankar says.
In addition to sharing its industry experience for the paper, Paragon developed the demonstration system, SharePoint configurations, workflows and sample source code to support the project.
Paragon Solutions, a Microsoft Gold Certified partner, is a business and technology consulting 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’s Life Sciences practice addresses the needs of the pharmaceutical, biotechnology, and medical device sectors. Our technology solutions are helping firms respond and capitalize on industry change driven by competition, consolidation, convergence and regulation.
For more information, please visit the Paragon Web site at www.consultparagon.com, or call 1.800.462.5582.