ERP built for the precision
life sciences
demands.
Unify compliance, operations, and financials in one system. Built for growth and tailored for the unique needs of pharma, biotech, and medical device companies, on Microsoft Dynamics 365.
Award-winning Microsoft partnership
Challenges We Solve
ERP challenges unique to life sciences & health.
Pharma, biotech, and medical device companies operate in one of the most regulated, high-stakes environments in the world. Most ERP systems were not built for it.
Regulatory Compliance Gaps
Managing FDA 21 CFR Part 11, GxP, ISO 13485, and EMA Annex 11 requirements across disconnected systems creates audit risk, compliance failures, and costly rework.
Lot & Batch Traceability
Without end-to-end lot and serial number tracking, a product recall becomes a crisis. Life sciences companies need complete traceability from raw material to finished product shipment.
Disconnected Systems
LIMS, QMS, and CTMS tools that don't connect to your ERP create duplicate data entry, errors, and slow decision-making across R&D, manufacturing, and supply chain.
Manual Processes & Spreadsheets
Paper-based batch records, manual audit trails, and spreadsheet-driven quality workflows are not scalable, error-prone, and put regulatory standing at risk.
Supply Chain Visibility
Cold chain management, expiry tracking, and global supplier coordination demand real-time inventory visibility that generic ERPs simply cannot deliver.
Scaling From Startup to Commercial
As companies move from R&D to commercial production, or toward IPO readiness, financial controls, multi-entity reporting, and operational infrastructure must scale with them.
Core Capabilities
- Lot and serial number assignment across procurement, production, and sales.
- FEFO (First Expired, First Out) picking logic to reduce waste and expiry risk.
- Rapid recall traceability, identify impacted batches in seconds.
- Electronic audit trails for every inventory movement and transaction.
- Full batch genealogy reports for regulatory submissions and audits.
- Electronic records and signatures aligned with FDA 21 CFR Part 11.
- Change control workflows and deviation management with CAPA tracking.
- Non-conformance tracking and quality event documentation.
- Audit trail automation to reduce manual compliance prep time.
- Pre-built validation documentation for IQ/OQ/PQ qualification protocols.
- GxP-aligned workflows for pharmaceutical and biotech manufacturing.
- Multi-warehouse inventory tracking with location-level visibility.
- Demand forecasting and automated replenishment.
- Cold chain and temperature-sensitive storage management.
- Supplier performance tracking and vendor quality documentation.
- Multi-currency, multi-entity global supply chain coordination.
- Integration-ready with QMS, LIMS, and MES platforms.
- Project accounting for clinical trials, R&D cycles, and grant management.
- Real-time visibility into production costs, COGS, and product profitability.
- Multi-entity financial reporting for complex organizational structures.
- IPO readiness with audit-grade financial controls and reporting.
- Revenue recognition across multiple sales channels and business units.
- Chargeback tracking, deductions, and contract pricing management.
- Microsoft Copilot in Business Central for AI-assisted forecasting and anomaly detection.
- Power BI compliance dashboards for real-time audit readiness reporting.
- Predictive analytics for supply chain disruptions, demand shifts, and batch deviations.
- Automated data classification to manage large-volume regulated data sets.
- Natural language queries to explore operational data without complex reporting tools.
Industries Within Life Sciences
Solutions across the life sciences spectrum.
Whether you manufacture drugs, devices, or diagnostics, Volt configures Business Central around your specific workflows and regulatory requirements.
Pharmaceutical
Batch record management, formula and recipe control, serialization, and GMP-compliant production workflows.
Medical Devices
Electronic device history records (eDHR), UDI compliance, ISO 13485, and FDA 21 CFR Part 820 workflows.
Biotech & R&D
Project accounting for clinical trials, R&D cost tracking, grant management, and IP lifecycle visibility.
Nutraceuticals & Health
Lot traceability, label compliance, ingredient sourcing, and demand forecasting for health and wellness brands.
Contract Manufacturers (CMOs)
Multi-client traceability, quality documentation per client spec, and production scheduling across shared facilities.
Diagnostics & Lab Services
Sample management, reagent inventory, result traceability, and billing workflows aligned with CLIA and CAP standards.
The Microsoft Advantage
A platform built for regulated industry.
Life sciences companies run on data integrity, security, and auditability. The Microsoft cloud infrastructure that powers Business Central was built for exactly that.
Why Volt
Every Volt sparks a new opportunity for growth.
We don’t just implement Microsoft Dynamics 365 Business Central, we transform operations, streamline processes, and empower teams with smarter, scalable solutions. Backed by a 30-year methodology and tailored for the way regulated industries operate.
What ERP is best for life sciences companies?
Microsoft Dynamics 365 Business Central is a strong fit for growing life sciences companies moving from startup to commercial operations. It offers robust financial controls, full lot and serial traceability, and can be configured for FDA and GxP compliance requirements. Volt Technologies specializes in implementing Business Central for pharma, biotech, and medical device companies.
Does Business Central support FDA 21 CFR Part 11 compliance?
Business Central can be configured to support key FDA 21 CFR Part 11 requirements, including electronic records, audit trails, and controlled access. Volt's implementations include change control workflows and quality event documentation to help life sciences companies build and maintain audit-ready operations.
How does Business Central handle lot and batch tracking?
Business Central includes native lot and serial number tracking across procurement, production, and sales. Every inventory movement is recorded and attributable. This enables rapid recall traceability, FEFO picking logic for expiry management, and full batch genealogy reporting for regulatory submissions.
Can Business Central integrate with LIMS, QMS, or MES systems?
Yes. Business Central integrates with laboratory information management systems (LIMS), quality management systems (QMS), and manufacturing execution systems (MES) through the Microsoft Power Platform and standard APIs. Volt designs these integrations to eliminate duplicate data entry and provide a single source of truth across operations.
What life sciences sub-industries does Volt serve?
Volt works with companies across pharma, biotech, medical devices, diagnostics, nutraceuticals, and contract manufacturers. Each sub-industry has unique regulatory and operational requirements, and Volt configures Business Central to meet those specific workflows.
How long does a Business Central implementation take for a life sciences company?
Implementation timelines vary by company size, complexity, and scope. Most mid-market life sciences implementations range from 3 to 9 months. Volt's implementation methodology includes a phased approach with milestones, change management support, and post-go-live continuous improvement to drive long-term adoption.
Ready to Modernize Your Life Sciences Operations?
Talk to a Volt consultant who understands regulated industries. We’ll help you evaluate whether Business Central is the right fit, and what a compliant, scalable implementation looks like for your organization.