Merit for Life Science
A cloud manufacturing ERP system for regulated industries like biopharma and medical devices built on Microsoft Dynamics 365.
Product Overview
Merit for Life Science extends the finance and operations capabilities of Microsoft Dynamics 365 to deliver an industry-specific ERP solution purpose-built for pharmaceutical, biotech, biopharma, and medical device manufacturers.
Designed for regulated environments, Merit for Life Science integrates quality management, procurement, materials management, production, and compliance into a unified platform that supports FDA 21 CFR Part 11, EU Annex 11, and other global regulatory requirements.
Merit Solutions brings deep life sciences expertise to every implementation. The experienced consulting team understands the complex intersection of manufacturing, quality, and regulatory oversight. They configure Dynamics 365 to meet those demands without unnecessary customization.
Pros
- Specifically built for the life science industry
- Comprehensive traceability and compliance across supply chain
- Automates quality and manufacturing processes
Cons
- Pricing is not listed publicly
Target Market
Process and discrete manufacturers in the pharmaceutical, biotech/life sciences, and medical device industries.Not Recommended For
Small organizations that don’t need a full ERP or aren’t considering Microsoft Dynamics 365.Key Features
Finances
- Auditable core accounting module
- GAAP, IFRS, SOC1-3 Sarbanes-Oxley compliant
Supply Chain Planning
- Perform demand forecasting and capacity planning to avoid bottlenecks and leverage “what-if” planning during shifting demand.
- Manage GxP documents, like supplier CMO/CDMO contracts, vendor certifications, and audits.
- Build accurate quality plans to ensure a smooth flow of materials through quality checkpoints.
- Automatic prioritization of stability and re-test quality to make the QC team more efficient.
Inventory & Warehousing
- Track inventory across every location, along with batches and sub-batches of materials.
- Ensure proper storage conditions, genealogy, and expiration.
- Track raw materials through the production process.
Quality Compliance
- Helps comply with 21 CFR Part 820 (now QMSR) and 21 CFR Part 11.
- Ensure electronic data is secure and traceable with audit trails and eSignatures
- Identify and log all quality incidents, including deviations, NCRs, and CAPAs.
- Perform quality inspections, audits, and validations
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