I need to track unstructured data, such as work instructions, specifications documents and standard operating procedures, in accordance with 21 CFR Part 11 regulations.

Although many solutions claim 21 CFR Part 11 compliance, the cost of these systems is often prohibitive for all but the largest life sciences organizations. At the same time, many solutions are difficult to deploy and even harder to use, which further limits their ability to create compliant-environments quickly and effectively. 

Merit Solutions has extended the capabilities of Microsoft SharePoint for use as a document management and quality control solution for life sciences companies, simplifying compliance with complete document lifecycle capabilities, including automated workflows, audit trails, digital signatures*, and full versioning support. MAXLife extends Microsoft Dynamics AX and Microsoft SharePoint to help address the regulatory requirements of FDA 21 CFR Part 11, as well as SOP management, clinical document management and a range of quality functions including CAPA, audits management, non-conformance and complaint management. 

With MAXLife for Microsoft Dynamics AX, Life Sciences companies can:

• Simplify the management of complex compliance processes
• Perform detailed audit analysis
• Protect data with more powerful security features
• Reduce administrative costs with new tools and formats
• Leverage Microsoft technologies

MAXLife helps organizations maximize investments in Microsoft technologies by leveraging strong capabilities of Microsoft Dynamics AX and Microsoft SharePoint Server for FDA / regulatory compliance.