ERP Software for Pharmaceuticals
Pharmaceutical manufacturers operate under the most stringent regulatory framework in manufacturing, with FDA 21 CFR Parts 11 and 211, EU Annex 11, cGMP, and DSCSA serialization requirements governing every aspect of production. ERP systems must deliver validated electronic batch records, full lot genealogy, potency and stability tracking, deviation and CAPA management, and complete audit trails that withstand FDA inspection and support global regulatory submissions.
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
Maintaining 21 CFR Part 11 compliance with validated electronic signatures, audit trails, and system access controls
Managing electronic batch records with deviation tracking, in-process testing, and master batch record version control
Ensuring cGMP compliance across all manufacturing, packaging, labeling, and warehousing operations
Meeting DSCSA serialization and track-and-trace requirements across the pharmaceutical supply chain
Managing complex stability testing programs and expiration dating based on real-time and accelerated stability data
Coordinating validated computer system lifecycles including IQ/OQ/PQ documentation and change control
Handling potency calculations, assay adjustments, and raw material variability in active pharmaceutical ingredients
Best Pharmaceuticals ERP for SMBs
Recommended for companies with $10M–$250M revenue and 10–200 employees.
BatchMaster ERP (Pharma Edition)
mid-rangeProcess manufacturing ERP with pharmaceutical-specific modules including electronic batch records, stability testing, 21 CFR Part 11 compliance, and potency management at an accessible price.
Best for: Small to mid-size pharmaceutical and nutraceutical manufacturers
Sage X3 (Life Sciences)
mid-rangeMid-market ERP with life sciences extensions for batch record management, quality management, regulatory compliance, and multi-site operations with validated deployment options.
Best for: Mid-size pharma manufacturers needing multi-site and validated ERP
ProcessPro (Pharma)
budgetDedicated process manufacturing ERP with pharmaceutical compliance features including lot traceability, quality control, and electronic batch records for smaller pharma operations.
Best for: Small pharmaceutical manufacturers seeking compliant, affordable ERP
SYSPRO (Life Sciences)
mid-rangeManufacturing ERP with pharmaceutical modules for batch traceability, quality management, and regulatory compliance alongside strong financial management.
Best for: Small pharma companies needing solid manufacturing and financial ERP
Aptean Process Manufacturing ERP
mid-rangeProcess-focused ERP with pharmaceutical industry capabilities including formula management, batch tracking, quality management, and compliance documentation.
Best for: Mid-size pharmaceutical manufacturers with complex formulation needs
Acumatica (Life Sciences)
mid-rangeCloud-native ERP with growing life sciences capabilities, strong API ecosystem for integrating with QMS and LIMS, and flexible consumption-based pricing.
Best for: Emerging pharma and biotech companies seeking scalable cloud ERP
Best Pharmaceuticals ERP for Enterprise
Recommended for companies with $250M+ revenue and complex multi-site operations.
SAP S/4HANA (Life Sciences)
enterpriseIndustry-leading enterprise platform with comprehensive life sciences solution including validated environment, ATTP serialization, batch management, GxP compliance, and global regulatory submission support.
Best for: Large pharmaceutical companies and global life sciences enterprises
Oracle Cloud ERP (Life Sciences)
enterpriseFull cloud ERP suite with life sciences modules for manufacturing, quality, compliance, and serialization, backed by Oracle's validated cloud infrastructure.
Best for: Large pharma enterprises pursuing cloud ERP with validated infrastructure
Infor CloudSuite Life Sciences
enterpriseFormerly Infor M3 Life Sciences, offering deep pharmaceutical manufacturing support with electronic batch records, quality management, regulatory compliance, and serialization.
Best for: Mid-to-large pharma manufacturers with complex batch manufacturing
Microsoft Dynamics 365 (Life Sciences)
enterpriseEnterprise platform with life sciences ISV solutions (e.g., Annata, Progressus) providing GxP validation, batch record management, and compliance capabilities on the Dynamics 365 stack.
Best for: Pharma enterprises standardizing on Microsoft with validated ISV extensions
Essential ERP Capabilities for Pharmaceuticals
21 CFR Part 11 compliant electronic signatures and audit trails
Electronic batch record management with master batch record version control
cGMP compliance workflows for manufacturing, packaging, and warehousing
Potency and assay management with raw material variability adjustments
Stability testing program management with expiration date calculation
DSCSA serialization and aggregation for track-and-trace compliance
Deviation, OOS (out-of-specification), and CAPA management with root cause analysis
Validated computer system lifecycle support (IQ/OQ/PQ documentation)
Quality management with incoming, in-process, and release testing workflows
Controlled substance scheduling and DEA reporting (for applicable products)
Pharmaceuticals ERP Cost Ranges
SMB
$100,000 – $350,000
10–50 users
Implementation: $100,000 – $350,000
Mid-Market
$350,000 – $1,500,000
50–250 users
Implementation: $300,000 – $1,200,000
Enterprise
$1,500,000 – $8,000,000+
250–5,000+ users
Implementation: $2,000,000 – $10,000,000+
Implementation Considerations
Budget for CSV (computer system validation) which typically adds 15–25% to implementation cost and 3–6 months to timeline
Define your validation strategy (GAMP 5 risk-based approach) early and engage your QA team as a core project stakeholder
Plan for 21 CFR Part 11 compliance verification including electronic signature workflows, audit trail configuration, and access controls
Ensure the vendor provides validated cloud infrastructure or supports validated on-premise deployments with proper change control
Map serialization and track-and-trace requirements (DSCSA, EU FMD) into the implementation scope from day one to avoid costly retrofitting
Frequently Asked Questions
What is 21 CFR Part 11 and how does it affect ERP selection?
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures. It requires ERP systems to provide audit trails, electronic signature workflows with meaning and authority, system access controls, data integrity safeguards, and validated operational states. Any ERP used in GMP-regulated pharmaceutical manufacturing must comply.
What does computer system validation (CSV) involve for pharma ERP?
CSV involves documenting and testing the ERP system through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. This ensures the system performs as intended in a GxP environment. Expect CSV to add 15–25% to project cost and 3–6 months to the timeline using a GAMP 5 risk-based approach.
How does pharma ERP handle electronic batch records?
Pharma ERP manages electronic batch records by maintaining version-controlled master batch records, guiding operators through production steps with electronic signatures at critical points, capturing in-process test results, documenting deviations in real-time, and producing complete batch documentation packages for QA review and release.
What ERP capabilities are needed for DSCSA serialization?
ERP must support unit-level serialization (SGTIN), aggregation (case, pallet), transaction documentation (TI, TH, TS), verification capabilities, and suspect/illegitimate product investigation. The system must generate and manage GTINs, serial numbers, and lot/expiration data in compliance with GS1 standards.
Can cloud ERP be validated for pharmaceutical manufacturing?
Yes. Leading cloud ERP vendors (SAP, Oracle, Infor) provide validated cloud environments with SOC reports, qualification documentation, and change management processes that support customer CSV efforts. However, the pharmaceutical company retains responsibility for its own validation activities and must verify the vendor's compliance claims.
How does ERP support deviation and CAPA management?
Pharma ERP provides workflows for documenting deviations during manufacturing, linking deviations to affected batches, triggering investigations and root cause analysis, generating CAPA records with assigned actions and due dates, tracking effectiveness checks, and maintaining a complete audit trail for regulatory inspections.
What role does ERP play in pharmaceutical quality management?
ERP integrates quality management across incoming material testing, in-process controls, finished product release testing, stability programs, supplier qualification, complaint handling, and annual product review. It ensures quality data flows seamlessly into batch records, regulatory submissions, and management review processes.
How long does a pharmaceutical ERP implementation take?
Pharmaceutical ERP implementations typically take 12–24 months including computer system validation. Small pharma companies may achieve go-live in 9–15 months with a focused scope. Large, multi-site implementations can extend to 24–36 months due to validation requirements, regulatory documentation, and phased site rollouts.
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