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
Compliance Base (required)
- Audit Trails
- Electronic signatures
- Product data controls
- GXP Documents:
- Automated document templates
- Not bound by legal entity for global quality organizations
- GxP Training:
- Audit tracked user sign off within D365 or power app
- GxP training dashboard
- Change Management:
- Risk assessments
- Impact assessments
Supply Chain Controls
- Batch details
- Batch/lot splitting
- labelling
- Batch change approval workflow
- Storage controls
- Procurement
- Warehouse requests (mobile app)
- Warehouse app batch inquiry options
- Warehouse location blocking
- Notifications for inventory approaching expiration and re-tests
- Inventory on-hand list page
Quality Management
- Quality incidents/events
- CAPAs, NCRs, deviations, complaints
- Risk assessments
- Root cause analysis
- Deviation effectiveness dates
- Integrated material disposition tracking
- Quality audits
- Non-material quality checks
Manufacturing Execution
- Dispensing and dispensing workspace
- Electronic batch report (EBR)/Device history report
- Quality orders for production floor execution (PFE)
- Recurring time-based quality checks
- Ad hoc quality testing in PFE
- GxP training controls
- Batch release dashboard
Quality Controls
- Quality inspections/testing
- Finished goods stability, expiration, and re-test with definitions
- Sampling rules
- Testing frequencies
- Quality planning
Video Overview
Product Overview
Developer Overview
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