ERP Archives - Expandable ERP

Medical device erp systems have become critical infrastructure for an industry projected to reach $615 billion by 2025 and $800 billion by 2030. This growth trajectory creates unique operational pressures, particularly since medical device manufacturing ranks among the world’s most heavily regulated sectors.

The stakes are considerable for manufacturers operating in this space. Medical device recalls recently hit a 15-year high, underscoring the urgent need for robust tracking and compliance systems. Both consumable and large capital equipment segments face intensified regulatory scrutiny.

Specialized erp for medical device manufacturers serves a purpose beyond standard operations management—it ensures regulatory compliance through automated validation processes and detailed audit trails. Every component and batch must be traceable to its source, creating the accountability and safety documentation that regulatory standards require.

Our evaluation covers dozens of medical device manufacturing software solutions to identify the 12 strongest options available today. The rankings reflect the distinctive compliance requirements, traceability demands, and manufacturing complexities that characterize this expanding yet strictly regulated industry.

Expandable ERP

Expandable ERP targets growing medical device manufacturers who require FDA compliance capabilities without the complexity of enterprise-level systems. The platform focuses specifically on high tech and med tech companies navigating the transition from startup to established business.

Expandable ERP key features

The system provides functionality designed around medical device manufacturing requirements:

Complete lifecycle traceability for serialized and lot-controlled items, tracking finished goods back to raw materials to satisfy government reporting requirements
Quality management foundation that supports quality procedures, incident tracking, corrective action, and root cause analysis
Surgical Kit module for tracking inventory consigned to hospitals, clinics, and surgery centers
Mixed manufacturing support allowing companies to build to stock, build to order, or configure to order within one system
Multi-level BOM tracking with serialized and lot-controlled components
Built-in compliance tools for FDA and ISO 13485 standards

The platform also handles product lifecycle management, CAPA, RMA processing, production control, inventory management, and integrated financial systems—all within complex medical device manufacturing environments.

Expandable ERP pros and cons

Pros:

Purpose-built for regulated industries with comprehensive compliance features
Scales with business growth from startup to established enterprise
Supports both discrete and process manufacturing environments
Offers both cloud and on-premise deployment options
Integrates entire operation from engineering to after-sales

Cons:

Less brand recognition than some enterprise-level competitors
Windows platform limitation may affect some deployment scenarios
As with most ERP implementations, requires careful planning to avoid pitfalls

Expandable ERP pricing

Expandable positions itself as “one of the most affordable, comprehensive, fully-integrated ERP systems on the market”. The company markets the system as budget-friendly for growing companies, making it accessible to startups and SMEs preparing to compete in the USD 955.00 billion MedTech market. Pricing structures aren’t publicly disclosed, but cost-effectiveness serves as a key differentiator.

Expandable ERP best fit

Expandable works particularly well for:

Medical device startups transitioning from prototype to production
Manufacturers of FDA-regulated medical equipment, diagnostic instruments, or implantable devices
Growing companies that need sophisticated compliance features without enterprise-level costs
Organizations managing mixed production methods including discrete builds, kitted surgical systems, and serialized diagnostic assemblies

Companies implementing specialized manufacturing ERP software like Expandable report 14% faster product delivery times and 10% more orders delivered on schedule. With 67% of medical device manufacturers struggling without specialized ERP systems, Expandable addresses a critical need for industry-specific functionality.

QAD

QAD has served as a trusted partner to medical device manufacturers for decades, delivering a robust medical device ERP system that targets the upper mid-market and lower enterprise sectors. The platform distinguishes itself through integrated supply chain components, supported by comprehensive ERP capabilities designed for regulated medical manufacturing environments.

QAD key features

QAD delivers a comprehensive toolkit specifically designed for life sciences manufacturers:

End-to-end supply chain visibility across manufacturing operations, including suppliers, customers, and outsource partners
FDA compliance tools supporting CFR Part 11, GMP, cGMP, and Eudralex Volume 4 regulations
Medical device-specific capabilities including serialization support for Unique Device Identification (UDI), Drug Quality and Security Act (DQSA), and Falsified Medicine Directive (FMD) compliance
Mixed-mode manufacturing with native discrete and process manufacturing capabilities plus forward and backward recall traceability
Integrated quality management system (QAD EQMS) built to adhere to ISO 13485:2016 standards
Model-driven architecture allowing customization without changing the source code

QAD pros and cons

Pros:

Strong supply chain perspective with deeper transportation and international trade management capabilities
Cloud maturity since 2008—significantly longer than competitors like SAP
Greater flexibility and easier configuration compared to SAP S/4HANA
Generally less expensive than SAP on both software and implementation
Serves customers across 60 countries generating USD 968.00 billion in annual revenue

Cons:

Limited brand awareness compared to SAP or Oracle, affecting executive confidence
Not as prolific a VAR ecosystem as Microsoft, SAP, or Oracle
Technology modernization announced but might take years to stabilize
Less suitable for manufacturers developing large complex capital equipment with thousands of dependent components
Smaller partner/consultant pool than SAP/Oracle ecosystems

QAD pricing

QAD typically costs less than SAP for both software licenses and implementation. The company structures pricing plans based on organization type and specific requirements. Detailed pricing information requires direct consultation with a QAD advisor.

QAD best fit

QAD works effectively for:

Mid-market to upper mid-market medical device manufacturers
Companies where supply chain management and traceability are priorities
Organizations requiring strong FDA compliance capabilities
Manufacturers operating mixed-mode production environments
Smaller enterprises using it as primary ERP or subsidiaries of larger companies using SAP/Oracle for corporate financial ledgers
Life sciences companies needing flexible solutions that adapt to changing business conditions

SAP S/4 HANA

For global medical device manufacturers managing complex compliance requirements, SAP S/4 HANA provides an enterprise resource planning solution designed for scale. This platform combines core business processes with advanced technologies to support highly regulated operations across international markets.

SAP S/4 HANA key features

Cloud-based architecture available in public and private editions, eliminating physical server requirements while providing worldwide data access
Intelligent technologies including artificial intelligence, analytics, and machine learning for operational optimization
Regulatory compliance tools supporting FDA requirements (21 CFR Part 11) and EU Medical Device Regulation standards
Real-time processing of massive datasets through the HANA in-memory database, critical for UDI tracking and serialized inventory management
Enhanced traceability capabilities connecting UDI data directly into manufacturing, warehousing, and logistics processes
Simplified data model reducing redundancy and complexity across operations

SAP S/4 HANA pros and cons

Pros:

Superior financial control with built-in visual workflow for each transaction
Real-time analytics enabling better decision-making and operational efficiency
Product model supporting various configurations and mixed-mode manufacturing
Enhanced scalability allowing medical device companies to expand operations efficiently
Advanced supply chain visibility across global operations

Cons:

Integration challenges with best-of-breed solutions despite robust options available
Excessive customizations and controls that may overwhelm smaller organizations
Limited last-mile medical device manufacturing capabilities requiring expensive customizations
Complex and potentially risky migration process from legacy systems
Steep learning curve for users transitioning from other platforms

SAP S/4 HANA pricing

SAP S/4 HANA typically costs between $250,000 in the first year to hundreds of millions for both licensing and implementation. The pricing model includes options for on-premise deployment (one-time fee plus 18-22% annual maintenance) or cloud subscription (monthly fees ranging from $20,000-$100,000). Named user licenses range from $1,500-$4,000 per user for on-premise or $100-$250 monthly per user for cloud deployments. Implementation services alone typically start at $75,000, with final costs depending on project complexity.

SAP S/4 HANA best fit

SAP S/4 HANA works effectively for:

Large, global medical device manufacturers with revenues exceeding $1 billion
Publicly traded companies requiring superior transactional traceability
Organizations managing compliance with strict regulatory requirements
Companies operating complex supply chains spanning multiple countries
Businesses seeking to modernize and consolidate enterprise systems
Medical device manufacturers requiring strong integration between ERP and quality management processes

Oracle Cloud ERP

Oracle Cloud ERP targets large medical device organizations requiring unified operations across complex business structures. With over 11,000 Fusion Cloud ERP customers worldwide, this platform addresses the operational demands facing major medical manufacturers navigating regulatory complexity.

Oracle Cloud ERP key features

Single data platform integrating finance, HCM, PLM, and supply chain data for enhanced product launch insights
Built-in AI capabilities that improve forecast accuracy for patient volume, revenue, and related expenses
Quarterly update cycles delivering new features every 90 days
Comprehensive supply chain management tools addressing the entire process from procurement to delivery
Regulatory compliance features minimizing risk and ensuring patient safety
Enhanced financial reporting with AI-powered management reporting narratives

Oracle Cloud ERP pros and cons

Pros:

Core ERP capabilities with deep supply chain and logistics functionality
Support for multiple business models within one global solution
Robust financial controls including SOX compliance and financial traceability
Cloud-native architecture reducing infrastructure costs
Strong integration between finance, HR, and supply chain functions

Cons:

Limited last-mile functionality for medical device manufacturing (device history records, FDA 21 CFR 11 reporting)
Extended configuration and customization timeframes
Less intuitive for plant-level employees due to complex interface
May require external support for customization implementation
Steeper learning curve for new system users

Oracle Cloud ERP pricing

Oracle follows a subscription model with monthly per-user pricing starting at approximately $500. The platform requires a minimum of 25 users to begin implementation. Implementation services typically start at $200,000, though final costs depend on project complexity and customization requirements. For detailed pricing information, Oracle recommends contacting their sales team directly.

Oracle Cloud ERP best fit

Oracle Cloud ERP serves large, global medical device manufacturers with revenues exceeding $1 billion. The platform works well for organizations managing diverse entities—including commerce, consumables, large equipment, consulting, contract manufacturing, and research center subsidiaries. It functions effectively as a corporate financial ledger for companies seeking to minimize subsidiary-level ERP systems. Organizations undertaking comprehensive operational transformation within the healthcare sector typically find maximum value in this platform.

Microsoft Dynamics 365

Microsoft Dynamics 365 provides a practical option for medical device manufacturers who need regulatory compliance capabilities alongside familiar Microsoft integration. The platform’s cloud-based foundation supports heavily regulated GxP environments while connecting seamlessly with established Microsoft business tools.

Microsoft Dynamics 365 key features

Complete lifecycle tracking with lot and serial traceability ensuring regulatory compliance from design through sales and service
Document management capabilities storing all regulatory and FDA requirements documentation in one central location
Quality control integration supporting test plans, defect reporting, and vendor quality assurance
Change order management tracking product modifications to drive continuous improvement
FDA traceability reporting with serialization and lot control for accurate patient information tracking
Business analytics providing deep financial and operational insights via Power BI dashboards

Microsoft Dynamics 365 pros and cons

Pros:

Natural integration with Microsoft ecosystem (Office 365, Teams, Forms)
Built-in quality and compliance modules for medical device manufacturers
Real-time production and inventory tracking capabilities
Flexible deployment supporting both cloud and on-premise options
Strong data security through Azure Cloud and Dataverse technologies

Cons:

Limited out-of-box automation requiring additional configuration
Complex implementation process requiring expert guidance
Higher initial investment compared to general-purpose ERP solutions
Performs best when operating within full Microsoft ecosystem
Industry-specific needs require customization

Microsoft Dynamics 365 pricing

Dynamics 365 operates on a subscription-based model with multiple licensing options. Sales Professional licenses start at $65 per user monthly, whereas Sales Enterprise licenses cost $95 per user monthly. For comprehensive deployments, implementation typically starts at $25,000. Business Central licenses range from $70-100 per user monthly, offering a more affordable entry point for smaller manufacturers.

Microsoft Dynamics 365 best fit

Dynamics 365 serves well for:

Medical device manufacturers requiring strong documentation capabilities
Organizations already invested in Microsoft technology stack
Companies prioritizing customer relationship management alongside manufacturing
Mid-sized manufacturers needing flexibility in deployment options
Businesses seeking integrated quality control with business operations

Acumatica Cloud ERP

Acumatica Cloud ERP provides medical device manufacturers with a unified platform built to address the particular challenges of operating in a heavily regulated environment. This cloud-based solution balances modern functionality with affordability, helping companies maintain operational control while meeting industry compliance standards.

Acumatica Cloud ERP key features

End-to-end traceability with lot and serial tracking from receipt to shipment
Quality management with embedded inspections, testing, and CAPA reporting
Regulatory compliance support for FDA and ISO 13485 standards
Engineering control with ECR/ECO workflows and structured approvals
Supply chain visibility providing real-time dashboards for inventory management
Cloud accessibility enabling teams to work efficiently across multiple locations

Acumatica Cloud ERP pros and cons

Pros:

Unlimited users with consumption-based pricing rather than per-user fees
Modern cloud platform offering seamless integration capabilities
Flexible, modular design supporting business growth without system overhauls
Direct integration of quality checks into manufacturing processes
Advanced document management for audit trails and traceability

Cons:

Can be expensive for smaller businesses requiring significant investment
Limited industry-specific features as a general-purpose ERP solution
Complex customization requiring specialized knowledge
Steep learning curve for new users due to comprehensive functionality
Reported issues with customer support quality

Acumatica Cloud ERP pricing

Acumatica’s pricing model differs from traditional per-user structures by charging based on applications and resource consumption. The General Business Edition starts at $6,396 annually for up to 10 users and 1,000 monthly transactions. Mid-sized businesses typically spend $25,000+ annually on subscription costs. Implementation expenses range from $60,000 to $100,000+ depending on complexity.

Acumatica Cloud ERP best fit

Acumatica serves growing medical device manufacturers particularly well when they need to:

Streamline operations while maintaining regulatory compliance
Improve operational efficiency and reduce compliance risk
Accelerate time-to-market for new medical devices
Manage multiple suppliers and complex production schedules
Scale their business without costly system replacements

The platform delivers the visibility, traceability, and control that medical device manufacturers need to meet strict regulatory standards while maintaining operational flexibility.

DELMIAWorks

DELMIAWorks (formerly IQMS) takes a different approach to medical device manufacturing software, built from the ground up with a “shop floor first” philosophy. This Oracle-powered system centralizes business activity across the entire supply chain while eliminating the complexity of managing multiple databases.

DELMIAWorks key features

The medical quality suite provides essential tools for device manufacturers operating under strict regulatory oversight:

Comprehensive compliance framework supporting ISO 13485/9001 standards, Current Good Manufacturing Practice (CGMP), and FDA requirements
Complete audit trail of manufacturing processes with secure electronic signatures complying with 21 CFR Part 11
Advanced tracking capabilities with unlimited track and trace, product identification, and serialization
Device History Record (DHR) module that automates collecting complete production history from design through the product lifecycle
Corrective Action/Preventive Action (CAPA) functionality with non-conforming product review and tracking
Optimized scheduling that identifies the best start time for jobs and constraints affecting delivery

DELMIAWorks pros and cons

Pros:

Single-source development ensuring less complex and more cost-effective implementation
Intuitive user interface resulting in training costs that are a fraction of competitors’ fees
Real-time monitoring system collecting data as jobs run, visible on a single screen
Built specifically for manufacturers by manufacturers, with ground-up development
Strong customer satisfaction with ease of use rated at 8/10 and functionality at 8/10

Cons:

Learning curve requiring ongoing training for full system utilization
Support sometimes functions as a sales team for training rather than direct assistance
Some users report labels taking too long to generate and system “locking up” during printing
Implementation requires experienced team members
UI described by some users as needing modernization

DELMIAWorks pricing

Per-user monthly costs start at approximately $150-250, with a minimum of 5 users required. Implementation services begin at $20,000, though final costs depend on project complexity. Total investment ranges from $25,000 to $300,000 based on organizational requirements.

DELMIAWorks best fit

DELMIAWorks serves Class 1, 2, and 3 medical device manufacturers who need robust traceability and regulatory compliance capabilities. The system works particularly well for companies operating in highly regulated environments where ISO and FDA compliance are non-negotiable. Organizations focused on quality management—specifically those requiring Statistical Process Control, CAPA, and detailed audit trails—will find significant value. Companies needing complete visibility from initial order through inventory, production, shipping, and final billing should consider this platform.

SYSPRO

SYSPRO ERP serves small and medium-sized medical device manufacturers with particular strength in consumables and diagnostic segments. The platform’s design reflects a clear understanding of distribution and commerce-focused operations that characterize much of the medical device sector.

SYSPRO key features

The system addresses core manufacturing requirements through integrated functionality. Full traceability capabilitiestrack materials from receipt through delivery, enabling manufacturers to rapidly identify potentially defective products. Electronic signature capture and comprehensive audit trails support FDA 21 CFR Part 11 and GMP requirements.

Real-time inventory visibility provides the operational control that medical device manufacturers require. Quality management tools improve governance while driving compliance. The platform’s native process manufacturing support proves beneficial for contract research organizations developing both drugs and devices.

Unlike many ERP solutions, SYSPRO offers customization options without affecting upgrade paths—a significant advantage for growing companies that need flexibility.

SYSPRO pros and cons

Pros:

Applicable across numerous manufacturing sub-industries with strong quality process focus
Out-of-box processes enable quick implementation without extensive customization
Customizable while maintaining upgrade capabilities
Strong inventory and supply chain management capabilities

Cons:

User adoption can be challenging with steeper learning curve for new users
Interface appears dated compared to modern ERP solutions
Self-service reporting limitations versus newer platforms
Primarily designed for smaller facilities with single legal entity structures

SYSPRO pricing

The subscription-based model starts at approximately USD 150.00 per user monthly. Organizations need a minimum of 10 users to begin implementation. Implementation services typically start at USD 25,000, with final costs varying based on project complexity. On-premise customers face higher upfront licensing costs depreciated over 5-10 years plus annual maintenance fees.

SYSPRO best fit

SYSPRO proves most valuable for SMB medical device companies, particularly those in consumables or diagnostic segments. Organizations requiring strong inventory and supply chain management find the platform well-suited to their needs. Companies needing robust quality controls and compliance documentation benefit from its integrated approach.

The system works best for single-facility operations rather than complex multi-entity structures. Businesses seeking customizable solutions that maintain upgrade paths will find SYSPRO addresses this common ERP challenge effectively.

Epicor Kinetic

Epicor Kinetic addresses the operational challenges facing medical device manufacturers who must balance regulatory compliance with efficient production processes. This AI-powered cloud ERP system targets the specific requirements of companies operating in highly regulated environments.

Epicor Kinetic key features

Regulatory compliance forms the foundation of Epicor’s approach, with specialized Life Sciences Cloud infrastructure supporting FDA CFR 21 Part 11 and EU Annex 11 requirements. Core capabilities include:

Comprehensive traceability with lot and serial tracking from raw materials to finished products
Quality management capabilities including complaint handling and corrective actions
Consistent upgrade cadence with deferred updates that maintain compliance
Microsoft Azure cloud infrastructure enhancing security and reliability

Epicor Kinetic pros and cons

Pros:

Mixed-mode manufacturing capabilities supporting various production methods
Superior user experience with advanced cloud-native features
Robust planning and inventory management tools
Detailed analytics and customizable dashboards

Cons:

Limited financial layers supporting only three hierarchical levels
Reliance on third-party quality modules
Learning curve requiring ongoing training
Report generation challenges noted by some users

Epicor Kinetic pricing

Per-user monthly pricing starts at USD 125.00 with a minimum requirement of 10 users. Implementation services typically begin at USD 50,000.00, depending on project complexity. Both leasing and subscription financing options help spread costs over time.

Epicor Kinetic best fit

Epicor Kinetic serves small to mid-market discrete medical device manufacturers effectively. The system works particularly well for companies managing complex inventory requirements where devices may serve multiple indications. Its distribution-focused planning capabilities make it suitable for commerce-oriented medical device organizations.

Infor CloudSuite Industrial

Small to mid-sized medical device manufacturers frequently select Infor CloudSuite Industrial for its dedicated quality management system and regulatory compliance tools. This ERP solution (formerly SyteLine) addresses the medical device sector’s distinctive operational challenges with specialized functionality.

Infor CloudSuite Industrial key features

Infor provides medical device production capabilities through its FDA Extended ERP solution framework. The platform incorporates advanced security features, comprehensive data auditability, and streamlined electronic record management. Core functionality encompasses batch records tracking, customer complaint management, and lot/serial genealogy for product traceability, along with electronic records support meeting 21 CFR Part 11 requirements. The built-in quality module maintains separate inventory for quality-controlled components while providing extensive in-process quality coverage.

Infor CloudSuite Industrial pros and cons

Pros:The system’s design reflects an OEM perspective with serializable unit support. Quality management integrates deeply into core operations, while field service capabilities coordinate resources effectively. FDA validation tools include packaged operational validation scripts.

Cons:The interface lacks a cloud-native feel with some critical limitations. The system proves unsuitable for distribution-centric medical device manufacturers. FDA-specific regulatory capabilities don’t match some competitors’ strengths, and the extensive feature set requires significant training investment.

Infor CloudSuite Industrial pricing

Per-user monthly pricing starts at USD 150.00 with a minimum requirement of 5 users. Infor’s subscription-based model scales with organizational growth. Leasing options help spread costs over time while providing potential tax benefits.

Infor CloudSuite Industrial best fit

Infor CloudSuite Industrial serves effectively as a subsidiary solution within large medical device companies or as the primary ERP for smaller manufacturers. The system excels where strict quality management and detailed product information are essential for meeting regulatory requirements. Medical device manufacturers needing to maintain ISO 13485 certification and FDA compliance will find particular value in this platform.

Rootstock

Built natively on the Salesforce platform, Rootstock delivers a medical device ERP solution that unifies compliance, production, and financial operations within a single system. This platform-native approach creates advantages for manufacturers already operating within the Salesforce ecosystem.

Rootstock key features

The system’s complete visibility and traceability over manufacturing operations automates compliance processes while maintaining the detailed documentation medical device manufacturers require. Real-time inventory analysis provides detailed tracking of costs and sales, giving manufacturers the financial insight needed for informed decision-making.

Rootstock has demonstrated measurable improvements in complaint handling, reducing timeframes by an average of 60%. The platform covers order management, inventory control, production, and supply chain planning through extensive functionality that connects directly with other Salesforce applications, creating a comprehensive business platform.

Rootstock pros and cons

Pros:

Excellent reporting capabilities with customizable interfaces
High customer satisfaction ratings of 4.7/5 from verified customers
Strong retention rates within the industry

Cons:

Some performance issues reported by users
Limited financial reporting capabilities
User interface needs improvement according to some reviews

Rootstock pricing

Rootstock structures pricing across three tiers: Growth starting from $100.00 per user, Advanced starting from $145.00 per user, and Enterprise with custom pricing.

Rootstock best fit

Rootstock works particularly well for medical device manufacturers requiring FDA compliance capabilities who want seamless integration with Salesforce. The system excels in environments needing robust traceability, quality control, and efficient complaint management processes. Organizations already invested in Salesforce infrastructure will find the native integration eliminates many of the complexity issues associated with connecting disparate systems.

Deacom ERP

Deacom ERP, part of ECI Software Solutions, operates on a distinctive “ONE” philosophy that sets it apart from other medical device manufacturers solutions. This unified platform targets companies requiring stringent FDA compliance and tracking capabilities within a single integrated system.

Deacom ERP key features

Deacom consolidates medical device manufacturing operations through targeted functionality:

Hyper-Tight Process Control™ with quality checkpoints across the complete product lifecycle
Native lot traceability maintaining regulatory compliance throughout supply chain operations
Document creation and management handling vendor scorecards, specifications, and compliance documentation
Real-time reporting with live transaction data posting

Deacom ERP pros and cons

Pros:

98% implementation success rate, well above industry standards
Single-screen operational visibility across all business functions
In-house support structure eliminating third-party dependencies

Cons:

Limited functionality for complex discrete manufacturing applications
Not suitable for large capital equipment manufacturers
Interface challenges reported by some users

Deacom ERP pricing

Deacom provides transparent pricing without hidden fees. Two main options include:

Deacom Essentials targeting SMB manufacturers seeking cost-effective solutions
Deacom Enterprise designed for established manufacturers with complex operational requirements

Deacom ERP best fit

Deacom performs strongest for diagnostic, drug, and smaller consumable device manufacturers. Companies distributing fast-moving medical goods requiring comprehensive track and trace capabilities will find the most value from this platform.

System Comparison Overview

The table below provides a side-by-side comparison of key specifications across all 12 medical device ERP systems. This reference helps manufacturers evaluate options based on their specific operational requirements and budget constraints.

ERP System	Key Features	Target Company Size	Base Pricing	Notable Pros	Notable Cons	Deployment
Expandable ERP	Complete lifecycle traceability, Quality management, Surgical Kit module	Growing companies, Medical startups	Not publicly disclosed	Purpose-built for regulated industries, Scales with growth	Less brand recognition, Windows platform limitation	Cloud & On-premise
QAD	End-to-end supply chain visibility, FDA compliance tools, Mixed-mode manufacturing	Upper mid-market, Lower enterprise	Less expensive than SAP	Strong supply chain perspective, Cloud maturity since 2008	Limited brand awareness, Smaller partner pool	Cloud
SAP S/4 HANA	Cloud-based architecture, Intelligent technologies, Real-time processing	Large global manufacturers ($1B+)	$250,000+ first year	Superior financial control, Real-time analytics	Complex migration, Steep learning curve	Cloud & On-premise
Oracle Cloud ERP	Single data platform, Built-in AI, Quarterly updates	Large organizations ($1B+)	$500/user/month	Core ERP capabilities, Strong integration	Limited last-mile functionality, Complex configuration	Cloud
Microsoft Dynamics 365	Complete lifecycle tracking, Quality control integration, FDA traceability	Mid-sized manufacturers	$65-95/user/month	Seamless Microsoft integration, Built-in quality modules	Limited out-of-box automation, Complex implementation	Cloud & On-premise
Acumatica Cloud ERP	End-to-end traceability, Quality management, Regulatory compliance	Growing manufacturers	$6,396/year (10 users)	Unlimited users, Modern cloud platform	Expensive for small businesses, Complex customization	Cloud
DELMIAWorks	Comprehensive compliance framework, Complete audit trail, DHR module	Class 1, 2, and 3 manufacturers	$150-250/user/month	Single-source development, Intuitive interface	Learning curve, Support issues	Not mentioned
SYSPRO	Full traceability system, Electronic signature capture, Quality management	Small and medium-sized	$150/user/month	Highly applicable across industries, Strong inventory management	Challenging user adoption, Older interface	Not mentioned
Epicor Kinetic	Regulatory compliance, Comprehensive traceability, Quality management	Small to mid-market	$125/user/month	Mixed-mode manufacturing support, Superior user experience	Limited financial layers, Reliance on third-party modules	Cloud
Infor CloudSuite	FDA Extended ERP solution, Batch records tracking, Quality module	Small to mid-sized	$150/user/month	Strong OEM perspective, Integrated quality module	Interface limitations, Extensive training required	Cloud
Rootstock	Complete visibility, Real-time inventory, Complaint handling	Salesforce-integrated companies	$100/user/month	Excellent reporting, High customer satisfaction	Performance issues, Limited financial reporting	Cloud
Deacom ERP	Hyper-Tight Process Control, Native lot traceability, Real-time reporting	SMB manufacturers	Not publicly disclosed	98% implementation success, Centralized operations view	Limited complex manufacturing, Interface challenges	Not mentioned

Conclusion

Selecting an ERP system represents a pivotal business decision for medical device manufacturers operating under strict regulatory oversight and operational pressures. Our analysis of these 12 solutions reveals distinct patterns in how different platforms serve various market segments within this highly regulated industry.

The medical device market’s rapid expansion means manufacturers face mounting pressure to maintain compliance while optimizing production efficiency. Your specific requirements for traceability, quality management, and regulatory adherence should drive the selection process.

Enterprise manufacturers with revenues exceeding $1 billion typically require the comprehensive capabilities of SAP S/4 HANA or Oracle Cloud ERP, which deliver robust financial controls and global supply chain visibility. Mid-market organizations often find better value in Microsoft Dynamics 365 or QAD due to balanced functionality and reasonable implementation costs. Growing medical device companies may benefit most from Expandable ERP or Acumatica, which provide industry-specific compliance features without enterprise-level complexity.

The right ERP solution must address your regulatory requirements—FDA compliance, ISO 13485 certification, UDI tracking. These systems become the operational backbone for maintaining audit trails, managing device history records, and ensuring complete lot and serial traceability.

Evaluate potential solutions based on your manufacturing approach, company size, budget parameters, and compliance obligations. Implementation timeframes, user experience, and ongoing support quality matter as much as core functionality when making this decision.

Medical device manufacturers implementing specialized ERP systems typically see improved compliance rates, enhanced operational efficiency, and reduced recall risk. This technology investment protects both business reputation and patient safety—two factors that define success in this critical industry.

The bottom line: choose a system that grows with your business while ensuring you never compromise on the regulatory compliance that keeps patients safe.

Key Takeaways

Medical device manufacturers face unique ERP challenges due to strict regulatory requirements and the need for complete traceability in a rapidly growing $615 billion industry.

• Specialized ERP systems are essential – 67% of medical device manufacturers struggle without industry-specific ERP functionality for FDA compliance and traceability

• Enterprise vs. SMB solutions differ significantly – Large manufacturers ($1B+) benefit from SAP/Oracle, while growing companies need scalable options like Expandable or Acumatica

• Compliance features are non-negotiable – Systems must support FDA 21 CFR Part 11, ISO 13485, complete lot tracking, and device history records

• Implementation costs vary dramatically – From $25,000 for smaller solutions to $250,000+ for enterprise systems, with pricing models ranging from per-user to consumption-based

• Real-time traceability drives ROI – Proper ERP implementation delivers 14% faster product delivery and 10% more on-time orders while reducing recall risks

The right medical device ERP system serves as your compliance backbone, ensuring patient safety while optimizing operations in this heavily regulated industry.

FAQs

Q1. What are the key features to look for in a medical device ERP system? Essential features include end-to-end traceability, quality management tools, regulatory compliance support (e.g., FDA 21 CFR Part 11), and integrated document management. Look for systems that offer real-time visibility into manufacturing processes and supply chain operations.

Q2. How does ERP software help medical device manufacturers maintain compliance? ERP systems designed for medical device manufacturers provide tools for maintaining detailed audit trails, managing device history records, and ensuring complete lot and serial traceability. They automate many compliance processes, reducing the risk of human error and supporting adherence to FDA, ISO 13485, and other regulatory standards.

Q3. What are the differences between ERP solutions for large enterprises versus small to medium-sized medical device companies? Large enterprise solutions like SAP S/4 HANA and Oracle Cloud ERP offer comprehensive functionality and global scalability but come with higher costs and complexity. Smaller companies often benefit from more specialized systems like Expandable ERP or Acumatica, which provide industry-specific features at a lower price point and are easier to implement.

Q4. How much does a medical device ERP system typically cost? Costs vary widely based on the size of the organization and the complexity of the system. Small to medium-sized businesses might spend $25,000 to $100,000 for implementation, while large enterprise solutions can exceed $250,000. Monthly per-user fees typically range from $100 to $500, with some vendors offering consumption-based pricing models.

Q5. What benefits can medical device manufacturers expect from implementing a specialized ERP system?Manufacturers implementing industry-specific ERP systems often see improved compliance rates, enhanced operational efficiency, and reduced risk of costly recalls. Benefits can include faster product delivery times, improved order fulfillment rates, better inventory management, and streamlined quality control processes. The right system serves as a backbone for maintaining regulatory compliance while optimizing business operations.

Project Lead

The project lead should be a key operational stakeholder. The project lead, for manufacturing companies, typically comes from the manufacturing, finance, or IT organization. I strongly recommend an IT employee not lead the project for a few reasons including the greater likelihood the project will be viewed as a corporate IT project (which it is not). Even the best IT employees do not understand the working requirement nuances of manufacturing and finance well enough, and it places the accountability on a support function as opposed to the people who will reap the benefits for the project’s success.

Cross Functional Teams

Core Team: It is imperative that an adequate number of key personnel from all impacted functions be assigned to the core implementation project team led by the Project Lead. These core team members will be relied upon to make/communicate important workflow decisions, obtain input at the appropriate time, and communicate decisions and status to the functional working team (discussed below).

Functional Working Team: Best practices have a separate working team for each function, led by the function’s Core Team member. The Core Team member’s responsibility to:

Be the project manager for the function they represent
Uncover any “gotchas” that need to be addressed prior to the ERP system go-live event
Communicate appropriate issues raised by the functional working team to the Core team
Drive tasks and open issues to closure
Ensure adequate resources are being assigned to the project within the function
Motivator and cheerleader for the functional working team members and across the function company wide

The 5 most common reasons, in no particular order of frequency, I have encountered through the years for delaying the “go” decision to obtain an ERP are:

We can’t afford it
The company is not quite ready
The decision maker does not perceive the value given the cost
We can get by for another year
Accounting’s reluctance to migrate off the off-the-shelf accounting system

Some of the above reasons could be very valid. For instance, I can agree with “getting by” for companies in survival mode caused by an economic downturn or a short term business situation. However, an objective of “getting by” should not be acceptable for any company trying to grow and realize more profits in the long run.

On the other hand, I will never be able to understand/agree with accounting’s comfort level being a determining factor in deciding to upgrade the company’s core operational system. If the accounting team is not comfortable, it is certainly understandable as it will be a big change. However, this should not drive the decision to “Go”, because an ERP system skill set is something that will eventually be required by most people in the company and simply delaying the decision is deferring too many benefits.

The remaining reasons might be eliminated through proper education, analysis and open discussions. The education might take the form of discussions with ERP knowledge/expertise, internal meetings or researching ERP benefits Ultimately, the key question to answer is “are the benefits derived from having an ERP system (e.g., improved, efficiencies, leveraging information across the company, lowering cost, improving customer satisfaction) outweigh the cost of the ERP system?”

With regards to the above question, it is important to note, one thing many people fail to consider is an ERP system might pay for itself if it helps eliminate any one of the below situations.

A lost sale caused by the inability to deliver the product to the customer on the date requested
Failure to meet regulatory compliance (FDA/CE compliance or Export compliance). One issue is one too many and can be devastating to a company’s survival
Lost repeat sales caused by customer dissatisfaction caused by incorrect shipments, late deliveries, and non-workable product configurations delivered
Excessive obsolete inventory due to the lack of timely communication between Engineering, Finance and Manufacturing regarding Engineering Change Notices
Additional headcount required to compensate for inefficiencies throughout the organization

Implementing an ERP is not an easy task, but it is not something to be feared if managed correctly. The implementation will impact many employees, but that impact cannot be avoided and is best accomplished when your team has more bandwidth and is able to devote more time to fix/optimize processes. In addition, the company will not only reap the benefits sooner, but employee morale will increase as their frustrations diminish when they stop using an inadequate system.

In essence, the best time to implement an ERP system is not when you are getting crushed by the waves of growth. It is far better to get slightly out in front of the waves in order for you to ride the waves to success.

The last blog focused on the top 5 critical elements that can only be determined by asking customers of the ERP system. The first element, Software Quality, was covered in depth in my prior post. The remaining four elements are discussed below.

Quality of the Vendor’s Customer Support Organization

Simple question; how much value-add can the ERP system deliver if you don’t know how to use it correctly?

In short, reference checking is the only source of truth in the ERP selection process for these other key elements that are often overlooked in ERP selection process. Not performing solid due diligence on these items will greatly increase the risk of a bad decision.

The quality of the vendor’s customer support organization will have a major impact on your company’s ability to obtain maximum value from the ERP system. In addition, a strong training culture and offering is a key component of a vendor’s overall product solution.

Access to knowledgeable customer support representatives is a significant benefit that can reduce the likelihood of critical delays due to user error. Imagine you’re trying to close the monthly financial records and the system is reporting huge manufacturing variances. Being able to call the support hotline and talk to an experienced professional who can calmly and logically walk through the most likely case scenarios, as well as more challenging situations, with you to resolve the issue is an insurance policy that holds tremendous value.

The key answers that you need to determine are:

Can I easily get direct access to the customer support organization or am I likely to be stuck in a monolithic bureaucracy?
How knowledgeable are the customer support front line employees?
What is the response time for help or issue resolution?
How do the support representatives treat their customers?
Will they “nickel and dime” us for every time we contact them?
Will we be dealing with a reseller or will we have direct access to the ERP vendor?

Time, Pain and Cost of Implementation and Data Migration

Every ERP sales person will tell you their implementations will be done on time, with little pain and the professional service fees will be on-budget. Do you simply take them at their word or would you feel more secure if you asked some recently completed implementations about their experience?

The probability of a successful ERP system implementation is directly proportional to the vendor’s success rate on other implementations as well as the planning done before the implementation has even begun. Given this, does the vendor offer a structured implementation plan – will you know what, when and who will be responsible to execute each step of the implementation before you begin?

Some questions that might prove eye-opening:

Is there a written implementation and training plan with responsibilities, milestones and dates?
Did the implementation take longer than expected? If “yes,” what was the main cause?
Were the consulting/professional service fees quoted enough to get the company “up and running” or were there significant overruns?
Was the quality of the training satisfactory?
How painful was the data migration?
Was the implementation team on-site or readily available during the first month-end close to ensure everything was going smoothly?

While there is an abundance of white papers on “How to Select an Enterprise Resource Planning System,” most articles tend to focus on functionality requirements, technology issues and total cost of ownership. Though it’s obviously important to verify that the product features, platform and price of a system meet the requirements of your organization, it is extremely important to understand that functionality is the only thing that a demo can provide. There are other elements that are impossible to ascertain from a demo or in discussion with the ERP vendor.

Due diligence on the less tangible elements of a vendor’s total solution – such as software quality, ease of implementation and responsiveness of customer support – can only be accomplished by asking other companies that have used or are using the ERP systems being evaluated. Not performing the same level of due diligence in checking references that was performed in examining product functionality invites critical shortcomings to remain hidden until well into the implementation process. By then it may be too late to change.

Top 5 Critical Factors

When checking references it’s important to ask the right questions. Product functionality questions are mostly resolved during the software demonstration process, so the objective of checking references is to measure the elements of a vendor’s total solution that cannot be reliably validated by the vendor through presentations and software demonstration. The Top 5 are:

Quality of the ERP software
Quality of the vendor’s customer support organization
Time, pain and cost of implementation and data migration
Scalability of the ERP software
ERP vendor’s commitment to your success

Quality of the ERP Software

Obviously, high quality software is an essential requirement in an ERP system. The frequency and severity of software bugs is a critical issue that can impact a company on many levels, from the consistency of financial reporting to the reliability of serial number and lot tracking. Software quality is an issue that cannot be resolved during the sales cycle in a demo or sales presentation. A sales engineer won’t provide a true representation of a system’s quality if they are having problems with a particular release or new product. Product specialists carefully script their demos to work around known issues so they do not come into play.

It’s especially important to gauge the quality of ERP systems that are new to the market or promote the fact that they are built on the latest technology platform. Sales reps will maintain that having the latest technology is a key advantage over a competitor’s more established system, but in many instances new software systems and products developed on emerging technology are unproven and lack market support and real world validation.

Usability is a quality issue that most vendors will claim, but is hard to validate without sitting down and using the software for an extended period of time in a real-world environment. One person’s definition of “user-friendly” can vary wildly from another’s based on the level of experience and simple preferences. If the system has bugs or shortcomings that require “work-arounds,” users will be tasked with performing multiple steps to achieve a routine outcome and will quickly become frustrated with the software.

Investigate the genealogy of the software. Who authored it? How many owners or name changes has it undergone? Was the product developed by the vendor or acquired through a merger or buyout? If the vendor is a reseller, do they have a position of strength with the software developer if needed? Gauging the quality level of a software system is an important consideration, and is an issue that can only be resolved outside the controlled sales environment. Talking to and asking questions of a good cross-section of individuals who are already using the system at their companies will be a good indication of the quality level of a system.

Questions to ask:

Is the product reliable? Does it do what it is supposed to do?
Does the system lock up frequently?
How many bugs are in the system?
Are there any work-arounds that you have to perform and how long have they been known issues?
How many software products does this vendor sell and support – are they focused on ERP?
If the vendor acquired the software:
- When did the acquisition occur?
- How many other platforms does the vendor sell/support?
- If multiple platforms are being sold it may result in customer support and/or development dilution. In addition, you’ll need to fully understand if you will be forced to migrate to a higher level platform as you reach your growth objectives.

I will continue the detailed discussion on the four remaining elements on my next post.

Tossing and turning at night is never fun, especially when the cause is concern over work related issues. There is an abundance of literature in medical journals regarding the negative impact on one’s health due stress or to a lack of sleep. Clearly, there would be a lot of demand for a product that could alleviate or even eliminate the stress and let you sleep at night. Even better if the cost of the product was reasonable and it actually allowed you to recoup your investment many times over.

I am sure you have heard the old axiom “if it sounds too good to be true, it usually is”. Well, in this case, I would say this doesn’t apply or at the very least it is worth your time to evaluate the product. What I am talking about is an alert system for your business, based on a set of self-defined rules waiting for an event to happen. The below are some examples of errors that could be prevented or actions that can occur with a proactive automated watch dog protecting your cash and profits while improving processes:

Shipping a customer order to European address with a US power cord
Notifying your sales people that one of their accounts just went on credit hold or is within 15% of their credit limit
A critical part in inventory just went below its safety stock level
An e-mail to your customers attaching the invoice for orders that shipped today
An e-mail to your buyer that notifies them about a new Engineering Change Order that will obsolete an inventory item and remind them as the cut-over date approaches

One can certainly make an argument that any one of the above examples where the prevention of an error, cost avoidance, and/or process improvement could very easily pay for the cost of an alerts module all by itself.

Another great example comes from one of our longtime customers. The owner was reviewing his records and was going back a few years to find something. By happenstance, he noticed that an invoice for a product shipment was sent that included a line item that had $0 for its list price. He couldn’t go back to the customer as the event was a few years in the past. This error literally cost him thousands of dollars. Right then and there he decided he didn’t want to even think about this happening again so “in order to sleep at night” he decided to purchase our alerts module.

The bottom line is the number of ways an alert system can help you and your business is almost limited by your imagination and creativity. How about a daily email alert that is sent at 6:00 every evening displaying the day’s bookings, shipments and cash collections amounts by customer?

A separate blog provides an overview regarding the five critical success factors needed to have a successful ERP implementation being:

Executive sponsorship/committee and support
Select a project manager
Cross functional team assigned
Training for all users
Test prior to “go-live”

The number one critical success factor is listed first for a reason. Without the CEO’s or COO’s full support of the project, the probability of success is dramatically decreased. A culture of Accountability with Consequences must be created combined with direct communication from the Company Executives. If the ERP implementation team and the rest of the company does not feel nor understand the sense of urgency and criticality of having a successful ERP launch, full participation from all business functions will not happen for the following five reasons:

Resistance to change

It is a well-known fact that people resist change at the work place (and in life) for numerous reasons including a) fear of the unknown, b) job insecurity and c) if they don’t understand the reasons for as well as the benefits to be derived by the change. Without the proper executive sponsorship, the wall representing resistance to change will be an entrenched obstacle.

Insufficient Communication

Two way communication with the Executive Sponsor is crucial in order to a) keep morale high even when a particular battle appears lost, b) provide strategic guidance and tactical direction to ensure that everyone is on the same page c) keep accountability high throughout the project, and d) inform the rest of the company of the progress being made as well as showing continued executive support and of the project.

Prioritization

Undoubtedly, along the way, there will be challenges for the company that appear that will test the company’s resolve of keeping the project on track keep it from getting derailed by all urgent matters that surface. All the company employees, managers will need to know that the Executive Sponsor is available to “make the call” and therefore have clear direction on task priorities in both the short and long term.

Performance Reviews

In most instances, an ERP system was obtained because the company is growing rapidly or needs to get the operations under control. Either way, employees are feeling stretched and stressed just trying to “hold down the fort”. Without Accountability with Consequences, employees will remain focused on getting their day-to-day jobs done at the expense of the ERP implementation as that is what they will be measured on come performance review time.

Measurement Yields Improvement

The old business adage of what gets measured improves is very relevant in this instance. Just knowing executives care and communication with executives will result in better results.

About the Author

Bob Swedroe is President and CEO of Expandable Software, Inc., a leader in manufacturing software development since 1983. Bob has held executive management positions at both start-ups and Fortune 500 companies including XO Communications, Silicon Graphics and Concentric Networks.

About Expandable Software, Inc.

Expandable Software, Inc. develops, markets and supports and enterprise resource planning (ERP) software suite designed to help fast-growing manufacturing companies maximize business performance.

Expandable’s fully integrated enterprise solution achieves a low total cost of ownership by delivering long-term deployment of a single system implementation.

With its unique model of direct sales and support, Expandable minimizes implementation costs and assures expert ongoing customer support.

Executive sponsorship, committee and support
Select a project manager
Cross functional team assigned
Training for all users
Test prior to “Go-Live”

Executive Sponsor

Without the CEO’s or COO’s full support of the project, the probability of success is dramatically decreased. A culture of accountability with consequences must be created combined with direct communication from the Company Executives. If the ERP implementation team and the rest of the company does not feel nor understand the sense of urgency and criticality of having a successful ERP launch, full participation from all business functions will not happen.

Project Lead

The project lead should be a person with broad knowledge of the company’s business, processes, have the ability to articulate the ERP solution vision, have respect of the executive sponsor/committee and the personality strength to work with and ability to communicate effectively across functional lines, the implementation team, and the Executive sponsor/committee. The project lead needs to be a strong communicator and have the ability to eliminate the resistance to change which will arise. The ability to communicate, coach and act decisively cannot be emphasized enough.

The project lead should be a key operational stakeholder. From my experience the project lead typically comes from the manufacturing, finance, or IT organization. I strongly recommend an IT employee not lead the project for a few reasons including the greater likelihood the project will be viewed as a corporate IT project (which it is not), even the best IT employees do not understand the working requirement nuances of manufacturing and finance well enough, and it places the accountability on a support function as opposed to the people who will be responsible for the project’s success.

Cross Functional Teams

Core Team: It is imperative that an adequate number of key personnel from all impacted functions be assigned to the core implementation project team led by the Project Lead. These core team members will be relied upon to make/communicate critical workflow decisions, obtain input at the appropriate time, and communicate decisions and status to the functional working team (discussed below).

Functional Working Team: Best practices have a separate working team for each function, led by the function’s Core Team member. The Core Team member’s responsibility to:

Be the project manager for the function
Uncover any “gotchas” that need to be addressed prior to the ERP system go-live event
Communicate appropriate issues raised by the functional working team to the Core team
Drive tasks and open issues to closure
Ensure adequate resources are being assigned to the project within the function
Motivator and cheerleader for the functional working team members and across the function company wide.

Training

Lack of proper training is one of the biggest reasons for failed deployments. Inevitably, users will be frustrated by their decreased productivity, inaccurate information and reports, and will ultimately blame the software for being too difficult to use.

The old British proverb penny-wise and pound-foolish is a perfect description for companies that invest a great of time and money to obtain an ERP system, but decide to save some money at the end by skimping on training. A few of the obvious benefits that will increase the probability of having a successful deployment by orders of magnitude, which proper training provides are:

Educate users how to use the system in their functional area. This will accelerate the learning curve on the proper and optimum way to use the system which leads to increase productivity
Provide users knowledge so they understand the impact of any errors they make on other users and the company
Reduce the level of frustration and angst in learning the new system

Without proper training, the chances of having a smooth and successful launch will be greatly reduced. In addition, improper use of the system will rapidly spread throughout the company has new employees will be instructed on improper use.

Test Prior to Go-Live

Testing should occur during the period between training and system Go-Live. Sufficient testing serves many purposes including making sure the users know how to use the system properly, the work flow processes that are going to be implemented are efficient, and the results are accurate.

If an issue is surfaced during the testing period, then more training is required, a work flow process needs to be modified; which may require additional training or perhaps a system setting or configuration needs to be modified.

About the Author

About Expandable Software, Inc.

Expandable Software, Inc. develops, markets and supports and enterprise resource planning (ERP) software suite designed to help fast-growing manufacturing companies maximize business performance.

Expandable’s fully integrated enterprise solution achieves a low total cost of ownership by delivering long-term deployment of a single system implementation.

With its unique model of direct sales and support, Expandable minimizes implementation costs and assures expert ongoing customer support.

One of the most important benefits of ERP systems vs off-the-shelf accounting packages is that information becomes available and leveraged across the enterprise as opposed to being stored in in stand-alone applications and made available only to a select few employees having access to the silo application. This benefit of shared/leveraged information is realized whether all the information resides in the ERP (e.g., informing the A/R department that a customer can be invoiced, because all product ordered has been shipped by manufacturing) or if the information resides in multiple applications that are effectively and efficiently integrated.

Integrations will be effective and efficient if the integration provides information in a timely manner and allows the user to use the application of their choice. For example, if a sales person uses the CRM system as their key tool, all the information they need to do their job should be viewable in the CRM application. Requiring a salesperson to log into the ERP system to view the information is by definition inefficient, will lead to frustration and will result in additional licensing costs for the ERP system.

The below narrative focuses on the benefits of having the ERP system integrated with the company’s Customer Relationship Management (CRM) system and with the Product Lifecycle Management (PLM) application.

ERP / CRM integration

The benefits of this integration are quite extensive, but a top level summary of the benefits include providing information or process improvements to Sales and Customer Support teams as listed below:

Sales Team

Orders not yet shipped by customer
Unpaid invoices by customer
Product and Pricing
Previous purchases by customer
Customer Support Tickets; opened and closed
Quote to Order Automation
Automation of adding a new customer to the ERP system

The above benefits can and usually do have a significant positive impact on the company’s Sales, Operations and Finance departments. By way of example:

Sales rep phone calls into Operations to see if a customer order has shipped will be reduced/eliminated.
Providing timely and accurate quotes as well as the ability to provide quick answers to customer questions regarding previous orders will increase customer satisfaction.
Automating both sales order entry and adding a new customer (with controls by Finance; i.e. new customers are given a status of “On-Hold” until approved by Finance) into the ERP system, will reduce errors and eliminate duplicate data entry.
The avoidance of walking into a customer and being surprised by a very unhappy customer, because the sales rep was not aware of a Customer Support ticket that has not been resolved.

Customer Support Team

Warranty information by serial number
Visibility into the customer’s installed product configurations

The visibility to the above information will:

Reduce warranty costs, because warranty validation is available to all customer support reps thereby eliminating providing free product/services to products no longer covered by an active warranty.
Customer Support reps will be able to increase customer satisfaction, because the customer’s installed product and configurations can be viewed while the rep is talking with the customer.

ERP / PLM Integration

The engineering department typically controls the Bill of Materials (BOM) for products the company manufactures by recording, tracking and releasing Engineering Change Orders (ECO) to existing BOMS and to enter BOMs for new products. If the engineers use the functionality embedded in the ERP system then this information is available immediately to all users of the ERP system. In addition, the engineers will have access to all the relevant information that is already stored in the ERP system to enable them to complete their tasks efficiently and cost effectively.

However, if an external PLM system is used without solid integration between the ERP and the PLM, this can lead to many inefficiencies and cost issues that could have been avoided had an integration existed.

The key benefits of having bi-directional integration between the ERP and PLM systems include:

Engineering: providing the Engineering department with information regarding product costs, inventory levels and open purchase orders. This will enable Engineering to:
- Design new products or redesign existing products with complete visibility to costing information for the parts used; i.e., design lower cost products
- Analyze existing inventory levels and purchase orders already placed so that a release or cut-over to a new design can be determined with proper consideration of potential inventory write-offs due to obsolescence or excess inventory
Purchasing: By providing the ERP system with approved ECOs and new product design BOMs, the Purchasing department will be in position to modify their inventory purchases to account for the change in the BOM. In fact, the ERP system itself should be able to provide a purchasing employee with a warning if they are entering a purchase order for an inventory part that has a ECO that has been approved.

These two examples serve to highlight the power and the importance of solid integrations between applications where the information in one of the applications is important to users of another application.