Collaboration is a core element of electronic document management and with ComplianceSP, QUMAS extends this key SharePoint 2010 capability to ensure full compliance with FDA CFR 21 Part 11 regulatory requirements. Combined with preconfigured solutions for managing document, processes, people and tasks, ComplianceSP delivers a unique and verifiable solution to all regulatory requirements, on the latest technologies.
"We have been approached by a number of firms that intend to make SharePoint 2010 a cornerstone of their technology infrastructure," said Kevin O’Leary, CEO, QUMAS. "Our deep Life Sciences expertise and relationship with Microsoft allows us to offer them a rich, scalable compliance solution that takes full advantage of their investment."

Each QUMAS ComplianceSP module offers a unique set of best practice compliance configurations, and is fully integrated with the wider ComplianceSP offering, to provide a seamless combination of best practices across all of your compliance initiatives. These modules include:

• Quality & manufacturing documents
• SOP documents
• CAPA & deviation management
• Change control
• Customer complaints management
• Audit management
• R&D submission documents
• Corporate compliance
• Sales & marketing collateral
• Contract management
• ISO management
• IT governance

"With ComplianceSP on SharePoint 2010, QUMAS is offering life sciences companies a solution that’s easy to manage and use, with compliance management capabilities in the familiar Microsoft interface," said Michael Naimoli, director of life sciences industry solutions, Microsoft. "SharePoint 2010 will also allow QUMAS to offer its customers the ability to manage documents, records and more on a single platform as well as reduce risk through features such as enforced retention schedules and tagged content."