MAXLife Life Sciences Quality Document Management Portal

MAXLife ERP > Life Sciences Business Challenges > SharePoint 21 CFR Part 11 Compliance

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.

MAXLife is a document management and quality control system for Life Sciences companies, simplifying compliance with complete document lifecycle capabilities, including automated workflows, audit trails, and full versioning support. Built completely on Microsoft SharePoint and .Net technology, MAXLife leverages the inherent components and capabilities, and familiarity for users, of the Microsoft platform while solving the specific controls, compliance, efficiency and quality challenges of Life Sciences companies.

With MAXLife, 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 the strong capabilities of Microsoft Dynamics AX and Microsoft SharePoint for FDA / regulatory compliance.

MAXLife ERP can dramatically improve profitability, productivity, and product safety at even the most complex organizations. Contact Merit Solutions to learn more about MAXLife ERP.

What FDA 21 CFR Part 11 Is and Is Not

Improve Internal Controls with Microsoft Dynamics AX