Merit for Life Science

Merit for Life Science is a cloud-first ERP solution purposely built for biotech, pharmaceutical, and medical device manufacturers. Built on Microsoft Dynamics 365 Finance and Operations, it extends and advances the platform's core capabilities to meet the complex, regulated requirements of life science organizations. Merit for Life Science connects the entire organization — from resource qualification mapping and vendor quality monitoring to full operational visibility — enabling companies to deliver safe, innovative products while maintaining compliance with FDA 21 CFR Part 11, EMA Annex 11, 21 CFR Part 820, GAAP, IFRS, SOC 1-3, Sarbanes-Oxley, the Sunshine Act, and other country-specific regulations.

Designed to drive process efficiencies, support rapid growth, and enhance organizational valuation, Merit for Life Science serves life science companies at every stage of their journey — from organizations outgrowing basic accounting packages to established manufacturers preparing for acquisition or investor scrutiny.

Finance

• Improve decision-making with reliable, auditable accounting practices
• Establish financial reporting standards for acquired entities or in preparation for acquisition
• Ensure compliance with GAAP, IFRS, SOC 1-3, Sarbanes-Oxley, and the Sunshine Act
• Organize, plan, and execute projects with full visibility and control over product costing
• Optimize financial operations, maximize profitability, and manage investments and risks

Sourcing, Procurement, Material and Asset Management

• Proactively audit and qualify vendors based on industry protocols
• Digitally control and enforce ordering exclusively from qualified GMP suppliers to prevent production disruptions
• Manage materials with automated testing protocols, advanced expiration and shelf-life tracking, re-test capabilities, and automated label printing
• Access a streamlined overview of key inventory data

Inventory and Warehousing

• Track and store inventory in multiple units of measure, including active ingredient content per unit
• Identify the location of every component — in stock, in finished goods, or at a customer site — using serial and lot numbers
• Track raw material handling throughout preparation stages, capturing process information in an auditable manner according to SOPs and batch requirements

Supply Chain Planning

• Build accurate supply chain projections incorporating procurement, quality, expiration, retest, manufacturing, forecasts, demand, and sales data
• Gain visibility and predictability across the supply chain to ensure resilience, avoid risks, and achieve operational responsiveness

Quality and Regulatory Compliance

• Leverage an extensible digital framework to simplify GxP compliance, including 21 CFR Part 820 and 21 CFR Part 11
• Manage quality test points throughout materials and production processes
• Track and manage complaints, incidents, significant deviations, adverse events, and material or process non-conformances with alerts and notifications at each stage
• Establish documented evidence of system and process consistency to prove a validated environment

Manufacturing Execution

• Electronically manage and document materials evaluation, potency, equipment calibration, and device and batch history records across multiple manufacturing modes
• Capture raw material handling information digitally, ensuring auditability and adherence to SOPs and batch requirements
• Streamline collaboration with contract manufacturing and research partners (CMO, CDMO, CRO) and standardize data flows for required manufacturing process information to ensure compliance

GxP Document Management

• Gain control over quality SOPs, validation documents, compliance documents, process-specific instructions, and analytical procedures
• Enable secure, controlled collaboration for both internal teams and external partners following GxP guidelines, ISO standards, and 21 CFR Part 11 compliance

GxP Training

• Personalize training by job role to make compliance easier for all personnel
• Automate qualification verification to prevent scheduling of unqualified personnel for production tasks and mitigate compliance risks
• Integrate with document management systems to ensure staff are always current on the latest regulations and SOPs

Right Start Pre-Configured Solution

• Offers a pre-configured ERP solution tailored to the life science organization's current needs and future growth
• Designed for companies outgrowing accounting packages or facing investor and compliance pressures
• Provides a scalable, budget-conscious path to full ERP capability

Merit for Life Science is delivered in a secure, modern cloud environment built on Microsoft Azure and supported by a partner ecosystem of Microsoft and Merit Solutions partners. The Merit Solutions team brings a proven track record of implementing and customizing integrated ERP, CRM, and BI solutions for life science manufacturers and other regulated industries worldwide, helping organizations transform business processes, improve profitability, accelerate growth, and maintain robust compliance.