Merit Solutions

4 reviews

Merit Solutions is a global Microsoft Dynamics AX Consultant and Mobile Solutions developer offering services for evaluating, implementing, extending, mobilizing, and supporting Microsoft Dynamics AX.

Merit for Life Science - Operations

0 reviews

Merit for Life Science-Operations advances the finance and operations (ERP) capabilities of Microsoft Dynamics 365 to deliver an industry-tailored solution that meets the rigorous requirements of pharma, biotech, and medical device organizations, including quality, procurement, materials management, production, and compliance. With Merit for Life Science, product owners and regulated manufacturers can drive increased process efficiencies, ready for and support rapid growth, and drive valuation while maintaining FDA CFR 21 part 11, EMA Annex 11, and other country-specific regulatory compliance. With Merit Solutions’ experienced implementation and consulting team, you gain a solution partner who understands the complex operational, manufacturing, and compliance challenges life science organizations face and has a demonstrated track record for supporting a successful digital transformation for product owners and manufacturing organizations including CMOs and CDMOs.

GxP Documents

0 reviews

Merit GxP Documents is a comprehensive document management and control solution tailored for life science organizations, including biotech, pharmaceutical, and medical device companies. It facilitates the entire document lifecycle—from creation and development to review, publishing, change management, and archival—ensuring compliance with GxP guidelines, ISO standards, and FDA 21 CFR Part 11 regulations. Key Features and Functionality: - Tight Document Control: Utilizes predefined document types to maintain consistent structure, manages documentation per GxP standards, and supports the complete document lifecycle. - Secure Collaboration: Enables internal and external teams to collaborate effectively within a cloud-based workspace with role-based security, ensuring clear accountability and separation of responsibilities. - Integration with Microsoft Azure: Built on Microsoft Azure, providing comprehensive security, compliance, and scalability. - Audit Trails and E-Signatures: Maintains robust audit trails and supports electronic signatures to meet regulatory requirements. Primary Value and User Solutions: Merit GxP Documents addresses the critical need for life science organizations to manage controlled documents efficiently while ensuring regulatory compliance. By automating document management processes, it reduces reliance on paper-based systems, minimizes errors, and accelerates approval cycles. The solution enhances data integrity, supports successful regulatory filings, and facilitates secure collaboration with partners, thereby improving overall operational efficiency and compliance readiness.