ERP Software for Pharmaceuticals
Pharmaceutical manufacturers operate under the most demanding regulatory environment in manufacturing: FDA 21 CFR Part 11 for electronic records and signatures, 21 CFR Part 211 Good Manufacturing Practice (GMP) requirements, and the Drug Supply Chain Security Act (DSCSA) for serialization and traceability. ERP systems in pharmaceutical environments must be formally validated, support formula and recipe management, manage batch production with full genealogy, and integrate with QMS platforms for deviation, CAPA, and change control management.
Compare ERP Systems for Pharmaceuticals
Select up to 4 ERP vendors to compare side by side. Filtered to show systems with strong pharmaceuticals capabilities.
Key Challenges for Pharmaceuticals
Achieving and maintaining 21 CFR Part 11 compliance for electronic records and signatures across all ERP transactions affecting product quality
Managing batch production with complete forward and backward traceability for raw materials, intermediates, and finished product lots
Complying with DSCSA serialization requirements for saleable units through the full pharmaceutical supply chain from manufacturer to dispenser
Coordinating formula and recipe management with quality and regulatory change control processes across product life cycles
Managing global regulatory submissions and maintaining product dossiers aligned with ERP product master data
Controlling raw material supplier qualification and incoming material testing under GMP vendor management requirements
Handling product recalls with complete lot traceability, customer notification, and regulatory reporting within FDA-mandated timeframes
Best Pharmaceuticals ERP for SMBs
Recommended for companies with $10M–$250M revenue and 10–200 employees.
BatchMaster
mid-rangePurpose-built process manufacturing ERP with deep pharmaceutical formula management, batch record generation, lot traceability, and quality management modules validated for FDA 21 CFR Part 11 environments.
Best for: Small to mid-size pharmaceutical and nutraceutical manufacturers
Sage Intacct
mid-rangeCloud financial management with strong cost accounting and multi-entity reporting for pharmaceutical companies that manage manufacturing in a separate validated system and need robust financial visibility.
Best for: Emerging pharma companies separating financial ERP from manufacturing systems
NetSuite
mid-rangeCloud ERP with lot tracking, serial number management, and financial capabilities used by emerging pharmaceutical and specialty drug manufacturers with validated configuration requirements.
Best for: Emerging pharma companies and specialty drug manufacturers
Microsoft Dynamics 365 Business Central
mid-rangeCloud ERP with formula management add-ons and lot traceability suitable for smaller pharmaceutical manufacturers with straightforward GMP documentation requirements.
Best for: Small pharmaceutical manufacturers with limited regulatory complexity
Acumatica
mid-rangeCloud manufacturing ERP with lot and expiration tracking, formula management via manufacturing module, and an open integration platform for connecting to validated QMS systems.
Best for: Growing pharmaceutical and OTC product manufacturers
Intact IQ
mid-rangeModern cloud ERP with strong distribution and inventory management capabilities for pharmaceutical wholesalers and distributors managing DSCSA-compliant serialized product handling.
Best for: Pharmaceutical distributors and specialty drug distributors
Best Pharmaceuticals ERP for Enterprise
Recommended for companies with $250M+ revenue and complex multi-site operations.
SAP S/4HANA
enterpriseGlobal standard for large pharmaceutical manufacturers with deep process industry capabilities, validated electronic batch records, serialization management for DSCSA, and integration to SAP QM for GMP quality management.
Best for: Global pharmaceutical manufacturers with multi-plant, multi-country operations
Oracle ERP Cloud
enterpriseComprehensive cloud platform with pharmaceutical manufacturing capabilities, lot genealogy, serialization, and strong financial management for global pharma operations. Oracle Life Sciences modules extend clinical trial and regulatory submission support.
Best for: Large pharma companies seeking full cloud transformation with regulatory capabilities
Infor CloudSuite Pharma
enterprisePurpose-built pharmaceutical ERP with batch management, formula and recipe control, GMP quality integration, and DSCSA serialization support validated for FDA regulated environments.
Best for: Mid-to-large pharmaceutical manufacturers prioritizing industry-specific depth
Microsoft Dynamics 365 Finance & Supply Chain Management
enterpriseEnterprise platform with process manufacturing, lot traceability, and advanced quality management capabilities applicable to pharmaceutical manufacturing with appropriate validation planning.
Best for: Pharmaceutical companies in the Microsoft ecosystem seeking enterprise scalability
Essential ERP Capabilities for Pharmaceuticals
FDA 21 CFR Part 11 compliant electronic records and signatures with complete audit trail
Batch production management with electronic batch records and batch genealogy tracing
Formula and recipe management with version control and regulatory change control integration
DSCSA serialization and aggregation for saleable unit traceability through the supply chain
Raw material supplier qualification and incoming material quality hold and release workflows
GMP deviation, CAPA, and change control process management integrated with production workflows
Expiration date and lot management with FEFO inventory consumption and quarantine handling
Product recall management with forward and backward lot trace and regulatory notification support
Stability study and shelf-life management linked to lot and batch records
Global regulatory dossier management and product registration data integration
Pharmaceuticals ERP Cost Ranges
SMB
$80,000 – $300,000
15–75 users
Implementation: $100,000 – $400,000
Mid-Market
$300,000 – $1,200,000
75–300 users
Implementation: $500,000 – $2,000,000
Enterprise
$1,500,000 – $10,000,000+
300–5,000+ users
Implementation: $3,000,000 – $20,000,000+
Implementation Considerations
Plan formal computer system validation (CSV) from project inception — pharma ERP validation under GAMP 5 is a multi-month activity that must be budgeted and resourced separately from technical implementation
Engage a qualified regulatory affairs consultant during requirements definition to ensure GMP workflows are correctly configured before user acceptance testing
Map serialization requirements under DSCSA at both the packaging line and supply chain levels early, as serialization integration with packaging equipment and third-party logistics providers is complex
Develop a master data governance strategy for formula, recipe, and material master data before migration — inaccurate master data in a validated pharma ERP can trigger regulatory observations
Plan change control processes for post-go-live ERP modifications — any change to a validated pharma ERP system requires formal impact assessment, testing, and documentation under GMP
Frequently Asked Questions
What is 21 CFR Part 11 and how does it affect pharmaceutical ERP selection?
FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures in regulated pharmaceutical environments. ERP systems used to create, modify, maintain, archive, retrieve, or transmit records required by FDA regulations must comply with Part 11. This means the ERP must provide complete audit trails, prevent unauthorized record alteration, enforce access controls, and support electronic signatures with unique identification. Vendor compliance claims must be verified through validation testing, not simply accepted at face value.
What is computer system validation (CSV) and is it required for pharma ERP?
Computer system validation (CSV) is the documented process of demonstrating that a computerized system consistently performs according to its specifications and predefined criteria for its intended use in a GMP environment. FDA expects pharmaceutical companies to validate any system that creates, processes, or stores GMP records. This includes formal risk assessment, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing following GAMP 5 principles. CSV activities add 3‒6 months and $200,000–$1,000,000+ to pharma ERP implementations.
What is DSCSA and what does it require from pharmaceutical ERP systems?
The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers, repackagers, wholesalers, and dispensers to serialize prescription drug packages at the saleable unit level, exchange transaction information electronically, and enable product tracing through the supply chain to facilitate rapid recalls. ERP systems must generate and manage GS1-compliant serial numbers, support EPCIS event reporting, manage aggregation hierarchies (unit-case-pallet), and integrate with trading partner systems for electronic transaction data exchange.
How does batch record management work in a pharmaceutical ERP?
Electronic batch records (EBRs) in pharmaceutical ERP capture all activities, materials, equipment, and quality checks performed during a production batch. This includes weighing and dispensing of raw materials with lot numbers, in-process testing results, equipment cleaning records, environmental monitoring data, and review and release workflows. Modern pharma ERPs generate the EBR template from the master batch record, guide operators through required steps in sequence, and capture electronic signatures at critical steps under 21 CFR Part 11.
What ERP systems are most widely used by large pharmaceutical manufacturers?
SAP S/4HANA and its predecessor SAP ECC are the dominant ERP platforms in large pharmaceutical manufacturing globally, with companies including Pfizer, Roche, Novartis, and AstraZeneca running SAP environments. Oracle ERP Cloud is gaining adoption among large pharma companies pursuing cloud transformation. Infor CloudSuite Pharma is a strong alternative for mid-to-large manufacturers seeking pharmaceutical-specific depth without SAP implementation complexity.
How does pharmaceutical ERP handle product recalls?
Pharmaceutical ERP recall management leverages complete lot genealogy to trace which batches of raw materials were used in which finished product lots, and which customers or distributors received specific lots. The system generates recall communications, tracks return quantities, manages quarantine and destruction workflows, and provides FDA-required reporting documentation. DSCSA serialization data further enables precise identification of specific serialized units in the recall scope.
What is the difference between pharmaceutical and nutraceutical ERP requirements?
Pharmaceutical ERP must be formally validated under GAMP 5 and comply with FDA 21 CFR Parts 11 and 211. Nutraceutical and dietary supplement ERP must comply with FDA 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements), which has similar lot traceability and quality record requirements but does not require the same level of computer system validation rigor as prescription pharmaceuticals. This distinction significantly affects implementation cost and timeline for dietary supplement manufacturers.
How do pharmaceutical ERP systems handle stability studies?
Pharmaceutical ERP stability modules manage scheduled stability study programs by tracking samples placed on stability at defined time points, scheduling and recording testing at each interval, maintaining complete expiry and shelf-life data linked to lot records, and generating regulatory submission-ready stability reports. This functionality is critical for determining product shelf life for label dating and for supporting regulatory agency review of stability data in drug applications.
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