Can you talk about ERP without using acronyms? Of course not – but it’s not a trick question. As one of our most common and cherished acronyms, “ERP” itself could almost have invented the TLA (the three letter acronym for three letter acronym).
Of course, it’s not that simple – ERP acronyms aren’t always three letters; and sometimes, the same letters may have different meanings to people from different industries. How confusing is that if you’re new to ERP or manufacturing?
The thing is, the humble TLA -- and other ERP acronyms -- represent a common language. Used appropriately, these expressions allow us to communicate ERP functions and benefits quickly and effectively.
Test your ability to “speak ERP” -- how many of the terms on the list below can you translate?
How many did you know immediately, without thinking? 14 or more? WOW! You must be an APICS founding member! 12 or more? Very good, you have definitely been around the block in the ERP world and know your stuff. 8 or less? You’ll need our handy Strategic ERP Acronym Translator below:
API: Application Programming Interface -- A protocol intended to be used as an interface by software components to communicate with each other.
ATP: Available To Promise -- The uncommitted portion of inventory or planned production available to be promised to new orders. ATP calculations can be used to verify whether an order can be filled within a specific time frame given other demands and currently scheduled supply orders. For example, during order entry, this lets you determine whether inventory will be available to meet a customer’s needs before you commit to a promise date.
BI: Business Intelligence – Software applications and technologies used to analyze an organization’s raw data and transform it into meaningful and useful information for business purposes. BI as a discipline is made up of several related activities, including data mining, online analytical processing, querying and reporting. Companies use BI to improve decision making, cut costs and identify new business opportunities.
CIM: Computer-integrated manufacturing -- The manufacturing approach of using computers to control the entire production process.
CRM: Customer Relationship Management: -- A widely implemented strategy for cultivating and managing your interactions with customers and leads. Provides a fully functional sales and marketing automation toolset designed to improve sales and marketing productivity, including communications and scheduling tools, pipeline and forecast management and customer service.
CRP: Capacity Requirement Planning -- Ensures that the resources, both equipment and personnel, are available to execute the plan. Together, an achievable high level production plan is achieved maximizing efficiency, and driving scheduling, procurement and execution.
EAM: Enterprise Asset Management -- An integrated plant operation solution that enables companies to operate plants more smoothly by keeping equipment running at the lowest cost. EAM manages planned and unplanned equipment maintenance, including calibrations, manages procurement of MRO inventory and manages capital asset project costs.
EDI: Electronic Data Interchange -- The direct transfer of data from one computer to another without the use of paper. EDI provides a streamlined method for managing communications between trading partners, including an end-to-end integration broker for B2B communications.
MRP: Material Requirements Planning (MRP) -- Addresses the need to ensure that materials are available to produce items at the correct time to meet customer delivery needs.
ROI: Return on Investment -- A performance measure used to evaluate the efficiency of an investment; calculated by dividing the benefit (return) of an investment by the cost of the investment; the result is expressed as a percentage or a ratio. Calculating the expenditure for an ERP project is fairly straightforward -- determining the gain is more difficult, because so many key benefits of a successful ERP project are intangible and unquantifiable. Tangible ERP ROI benefits include reduced costs and increased throughput; intangible benefits include things like regulatory compliance (invisible if you get it right, costly if you don’t), accuracy and process improvement.
SaaS: Software as a Service -- Delivering software over the Internet or “Cloud computing”; often associated with a “Pay as you go service”.
SCM: Supply Chain Management -- Integrates supply and demand management within and across companies. It includes important variables such as the planning and management of all activities involved in sourcing and procurement, conversion and all logistics management activities. SCM can also include coordination and collaboration with channel partners, which can be suppliers, intermediaries, third party service providers and customers.
SOP: Sales Order Processing – In ERP, SOP does not mean standard operating procedure. The process where customer orders are received, checked for creditworthiness then for product availability; and arranging for delivery to customers is done; finally billing and maintaining records of amounts due from customers is carried out.
S&OP: Sales and Operations Planning -- A decision-making process that realigns the tactical plans for all business functions in all geographies to support the company's strategies, business goals, and targets. A process led by senior management that evaluates and revises time-phased projections for demand, supply, product and portfolio changes, strategic projects, and the resulting financial plans.
TMS: Transportation Management System -- Provides a complete set of tools to optimize shipments by air, sea, parcel, truckload or less than truckload; provides international documentation and assists in compliance with denied party regulations.
UI: User interface -- The parts of a computer and its software that the user can see, hear, touch, or talk to; the set of all the things that allow user and computer to communicate with each other. Like any good communication channel, a user interface is a two-way street. The best user interfaces are the ones users don't have to pay much attention to. When an interface is easy to use, users can spend their time doing work instead of looking for the right button or key. It's almost transparent--users can see right through the interface to their own work.
What we learned at QAD Explore 2013: Ten building blocks for the Effective Enterprise
Today’s manufacturers must constantly adapt their businesses to address new market challenges. Effective enterprises leverage new technologies to drive productivity and performance for their organizations, their supply chains and their customers.
That’s why QAD Explore 2013 showcased the technology tools and information that enable manufacturing organizations to become more effective enterprises. QAD delivers tools and technologies that help companies streamline application maintenance and continuously improve key business processes.
QAD Explore is always exciting! Here are our ten key takeaways from this year’s conference:
QAD Enterprise Applications 2013 delivers significant enhancements – QAD continues to evolve QAD Enterprise Applications to help businesses operate more efficiently, adapt to change more easily and ensure business continuity. Robust architecture, fresh functionality and enhanced usability make it simple and easy for QAD customers to maintain, support and upgrade individual components while continuing to leverage the existing system.
Innovative framework simplifies application support – A new modular deployment framework provides the ability to enhance or upgrade individual components, elements and services within QAD Enterprise Applications. The simplicity of this framework eliminates disruption from replacements of the entire application. QAD users can access a variety of components online from the QAD Store and add them to their systems easily.
New capabilities support item attributes, traceability and quality control – With enhanced capabilities to address mandates for product traceability, the new quality control functionality supports detailed recording of item quality attributes and traceability of materials throughout the supply chain. These capabilities support both current and emerging regulatory requirements, like ePedigree and Unique Device Identification (UDI) in the Life Sciences markets. Serialization/Unique Device Identification (UDI) enhancements are in development.
New capabilities in QAD Enterprise Financials –QAD Enterprise Financials is designed to meet the needs of global public companies with support for regulatory and governmental compliance mandates such as Sarbanes–Oxley (SOX) and the adoption of International Financial Reporting Standards (IFRS). Complete retro-billing capability accommodates fluctuating commodity prices and allows for retrospective price adjustment and on-charging to the customer. This capability combined with the strong logistics accounting capabilities that manage shipping and freight costs before and after the event safeguard businesses against inaccurate freight and material cost variances.
Roles-based usability enhancements – QAD continues to enhance its leading-edge user interface (UI) technology. In the latest release, QAD delivers an advanced role-focused metaphor. This new metaphor collects the functionality a user requires to perform a specific role, via a simple configurable home page. From this home page users can execute their regular functions with a few clicks while maintaining constant visibility of key metrics and assigned tasks. QAD expects to build on this metaphor in the future to further enhance the user experience across the enterprise.
Enhanced deployment flexibility – Building on its goal to simplify upgrades for its customers, QAD’s application architecture enables enterprises to implement a full-strength ERP solution in the cloud, on premise or as a blended deployment containing a mix of on premise and cloud users. Customers enjoy the same complete functionality, business processes and user experience regardless of how their QAD Enterprise Applications solutions are deployed.
DynaSys acquisition delivers cutting edge Supply Chain Management (SCM) functionality – Ariel Weil, general manager of DynaSys, a division of QAD, highlighted advanced demand and supply chain planning solutions users will soon be able to take advantage of.
Cebos acquisition delivers new Quality Management Systems (QMS) functionality – Recent addition to the QAD team Bob Herdoiza, president of CEBOS, a division of QAD, introduced new capabilities to support Quality Management, Regulatory Compliance and Regulatory Control. Stay tuned for more details on how you will be able to leverage these capabilities.
Emerging trends – Tony Winter, chief technology officer at QAD, delivered insights into emerging trends like BYOD (Bring Your Own Device), and how QAD products will help you leverage them -- featuring the latest in mobile ERP, business process management (BPM), Big Data and other technologies.
QAD 2013 Global Partner Award Winner – Strategic Information Group was recognized as QAD’s North American Channel Partner of the Year at Explore. Look for more about QAD Enterprise Applications 2013 and evolving trends in enterprise computing in future issues of Strategic Unleashed. And save the date for QAD Explore 2014, May 5 - 8 in New Orleans!
Lifting the fog around cloud ERP: 11 critical considerations shed light on your decision
The ERP landscape continues to change radically, as more and more traditional, on-site ERP vendors offer their solutions delivered via a cloud-based, software-as-a-service (SaaS) model.
SaaS ERP can provide a relatively inexpensive way for companies to streamline business processes and maintain that competitive edge. On-site ERP deployments require large capital outlays and specialized IT resources. ERP SaaS solutions offer economic advantages like minimal capital expenditure, less financial risk, faster deployment and quicker time-to-market that allow for a quicker return on investment because it offers
Despite the hype, cloud ERP is not a panacea – and on-premise ERP is not going away. Still, cloud is now a key consideration in any ERP strategy. When your system is at the point in the ERP lifecycle where you’re considering an upgrade or migration, it’s a great time to rethink your ERP strategy and consider SaaS ERP.
These 11 tips will shed some light on the cloud ERP decision process:
Examine the differences between on-premise and off-premise ERP scenarios: On premise ERP; the software is licensed, installed at the customer’s site; plus maintenance. SaaS is most commonly delivered via the Internet in the cloud; companies pay monthly subscription fees.
Get to know the infrastructure tradeoffs: Is your existing network infrastructure solid enough to handle running ERP in the cloud? Is your staff knowledgeable about cloud networking requirements? There’s a good chance you’ll reduce network costs. Other network-related issues include compliance, security and ensuring adequate bandwidth and Internet access.
Understand the different types of clouds: The two major types of clouds are: private, for the exclusive use of an organization, typically managed by in-house IT; public, shared, hosted and managed by an external service provider.
Consider a hybrid approach: Another option is for companies to use a combination of on premise and SaaS ERP. A recent Forrester survey of 2,403 IT decision-makers showed that 10% of planned implementations will use ERP SaaS to complement existing on premise ERP.
Weigh cost considerations: The main reason ERP SaaS can be a very economical solution for small-and-medium-size businesses or start-up companies is relatively low initial TCO. Implementation, consulting and overall acquisition costs, along with the limited need for extensive IT infrastructure, make SaaS ERP an attractive option.
Appreciate industry-specific requirements: Industries where there are highly complex operations may not be a good fit for ERP SaaS due to the level of customization that may be required. Recently, ERP SaaS adoption has picked up considerably in life sciences and other sectors that require strong compliance capabilities.
Get the right level of control: You have to make strategic decisions about appropriate levels of control of your data, modifications, and configuration. The very nature of SaaS ERP requires you to relinquish control of software, maintenance and upgrades. But if you don’t like the service you receive from your SaaS provider, get rid of them and find another vendor.
Ensure accessibility and reliability: Even though SaaS provides tremendous flexibility in terms of enabling users to access anytime, anywhere, SaaS access relies on Internet access. SaaS solutions have become very reliable. Reliable vendors have extensive disaster recovery plans in place so that quick restoration of data can take place in case of an emergency.
Think about IT resource constraints: Even if you have the right skill-set to deploy ERP on-site, the number of resources required will be far greater than with a SaaS deployment. If you don’t have the in-house expertise required to undertake a potentially long and extensive on-site ERP deployment, SaaS ERP may be a better option for you.
Know your customization requirements: SaaS ERP is best suited to enterprises that don’t want or need a high degree of customization. In industries where processes are very complex, you need to take this into consideration.
Determine your need for speed: If quick deployment is high priority, then SaaS ERP could be a better option for you.
When bad things happen to good products: Can your ERP handle a product recall?
You care about the safety and wellbeing of your customers and have the utmost desire to cause them no harm. But product recalls happen to the best of companies. Failure to handle a recall successfully can have serious economic and legal consequences. The resulting damage to your company’s reputation can be long-term or permanent.
That’s why it’s more important than ever for manufacturers – especially FDA-regulated companies – to have effective recall management solutions in place. If your enterprise resource planning (ERP) solution lacks the capabilities to help you handle a recall, you are leaving your company open to unnecessary risk.
When a product recall becomes necessary, companies must be able to quickly and accurately:
- Determine where all product inputs originated.
- Determine where the products in question are and how to get them returned, from retailers, wholesalers, customers or transporters with product in transit.
- Provide information – to customers, the general public, media and regulatory agencies governing your industry or product.
A critical ERP capability to support fast, accurate, documented product recalls is traceability. The question is, can your ERP help you identify who supplied, handled, transported, received, stored or bought each product lot, and can it do so with alacrity?
You need a lot tracking system that provides integration with your key business processes and systems, and enables forward and backward track and trace so you can determine the source of a problem to the lot level.
Integrated lot tracking capabilities cross key business functions like accounting, inventory, purchasing and sales. Comprehensive warehouse management functionality includes radio frequency identification (RFID), bar coding, scannable labels, quality management and electronic data interchange (EDI). Just as important, lot tracking provides the necessary accuracy and timely access to records to support compliance.
Advanced ERP solutions also help your employees respond effectively, with enforced workflows and controls that ensure the proper business processes are being followed in accordance with FDA or other regulations and standards. Full transparency into the recall process allows users to quickly notify the customers affected by the recall, track the status of a recall and confirm that 100% of the recalled product was pulled. Just as important, these systems provide complete, accurate documentation that your company precisely followed appropriate recall procedures.
An ERP solution with comprehensive recall management functionality positions your company to plan the recall process in advance. You can constantly measure and improve the recall process to help ensure rapid, accurate, and thorough response in the event of a recall.
You’ve spent a lot of time and money getting your company’s product into the market. No one wants to deal with a product recall, but an effective and well-managed response can mitigate liabilities and protect your company’s brand. With the right ERP in place, your company has a much better chance of surviving a product recall and turning crisis into opportunity.
For manufacturers, the Software as a Service (SaaS) ERP deployment model is truly a game changer. Today’s SaaS ERP securely and reliably delivers all the capabilities manufacturers need to improve response time, meet compliance requirements, increase customer satisfaction and drive measurable performance.
ERP on demand provides an alternative to traditional, on-premise enterprise software that offers low cost and high performance. The SaaS delivery model turns ERP acquisition from a cash-intensive capital expenditure into a more manageable operating expense – with less effort and risk.
SaaS ERP helps manufacturers deliver business results. QAD’s SaaS ERP solution, QAD On Demand, offers security, reliability, availability and predictable expense, helping you minimize your risk while maximizing return on investment.
QAD On Demand helps manufacturers make the most of these seven powerful SaaS ERP opportunities:
Complete Integration: Today’s SaaS ERP is designed to support all of the key processes of global manufacturers. It enables measurement, process control and process efficiency, and is configured with built-in industry best practice processes. QAD On Demand delivers a fully integrated ERP and Supply Chain business solution designed for fast deployment, optimum user productivity and easy upgrades.
Manufacturing Capabilities: SaaS ERP delivers the tools manufacturers need for planning, scheduling, cost management, material control, shop floor control and reporting. QAD provides full shop floor control throughout the manufacturing process, and tracks performance and quality.
Always up to date: One of the most powerful savings SaaS ERP offers is an easier upgrade path and lower upgrade expense. Organizations avoid the costs and disruptions of upgrading – and the temptation to delay the purchase of updates that could enhance effectiveness and provide competitive advantage. When QAD On Demand customers request a software change or new function, the QAD developers make the change and release it to the person who requested it, and also make it available to the entire network. This rapid, on-demand development supports continuous improvement.
Usability, efficiency, productivity: SaaS ERP vendors strive to make it easy for users get up to speed fast and enjoy continuous improvement. That’s why QAD continuously improves its simple, customizable user interface, QAD .NET UI. And, QAD process maps make it easy for companies to establish repeatable procedures and deploy them across business units. These tools enable faster onboarding of new users and greater productivity across organizations.
Qualified for Validation: With this model, one instance of the SaaS ERP application is hosted in a single-tenant private cloud. The core functionality of the application needs to be validated just once. You don’t have to worry about getting systems and IT procedures documented and certified, which is a huge time and money saver. QAD On Demand provides a separate qualified environment to each customer. Just as important, QAD software and procedures meet strict FDA regulations. QAD’s qualified environment also allows compliance with current Good Manufacturing Practices (cGMP) with no additional investment in systems infrastructure.
Quality Management Included: For some manufacturers, quality management is as important a requirement as compliance capabilities. QAD’s Cebos Enterprise Quality Management MQ1 provides the functionality to meet ongoing quality system requirements. Users can configure to business process requirements, to ensure meeting international compliance requirements, ISO standards, FDA requirements, and individual customer requirements.
True Process Improvement: Manufacturers need to be able to define the best practices for their business processes, and measure their efficiency. QAD defines an Effective Enterprise as one where every business process is working at peak efficiency and perfectly aligned to the company’s strategic goals. QAD’s Effective Enterprise philosophy drives the development of solutions that encompass best practices and deliver clear measurement.
ERP has come a long way in the past few years, evolving in unanticipated ways with technologies and in the marketplace. Cloud computing, mobile technologies, and social media mean new opportunities and challenges for the enterprise systems.
ERP still does what it has always done well. ERP collects, manages and distributes information across the enterprise to drive efficiency, quality and productivity. By breaking down information barriers to cooperation and collaboration between critical business functions, ERP helps companies accelerate time-to-market, shorten lead times, reduce costs and improve customer service.
Now that ERP survived the Mayan apocalypse, here are several ideas to consider for improving your ERP in 2013:
ERP in the Cloud – The cost benefits of migrating to a cloud-based ERP make it well worth considering for all companies. Cloud-based solutions and services are easy to deploy, integrate and upgrade -- and they don’t require additional investment in IT infrastructure and staff. Bringing your business into the cloud can be especially beneficial for businesses that anticipate rapid growth, have limited IT infrastructure, seasonal spikes or multiple locations.
Powerful Analytics - Today’s advanced enterprise analytics empower organizations to anticipate change and react effectively to shifts in the dynamic business environment. Integrated analytics capabilities extract and enhance the data in your company's ERP to help you make smarter decisions, faster.
Mobile ERP - To stay competitive, companies are rapidly moving toward a more mobile enterprise model. Mobile ERP tools help companies create better ways for end users to access and interact with information. With mobile ERP apps, mobile workers get easy access to powerful functionality and real-time data anywhere, any time.
Social ERP - As the next generation of ERP systems emerges, social applications are proving their value in connecting businesses internally and with customers. By facilitating collaboration and communication among employees and partners using your ERP system social ERP tools can enable them to proactively solve business problems together.
Easier Configuration - Leading ERP applications provide a full set of functionality and pre-integrated modules, and optimized interfaces – that means configuration is much less costly than it has ever been. Next-generation ERP solutions allow organizations to quickly create new processes, improve existing ones, and add functionality as the needs of the business change. As the need for enhanced functionality increases, these capabilities can be "turned on" for little or no additional license fee.
Today’s ERP solutions deliver return on investment almost out of the box, with easier configuration, cost-effective cloud-based options, and sophisticated analytics. Mobile and social alternatives can help users deliver better service levels and improve productivity. These solutions offer enterprises of all sizes unprecedented opportunities to drive business performance and competitive advantage.
It’s nearly impossible for typical Enterprise Resource Planning (ERP) systems to keep pace with changing business needs.
Aging ERP systems create complexity, duplication of effort, and a dangerous lack of visibility into the business. Quality and customer service begin to deteriorate.
Any one of these warning signs could mean the death of business performance and competitive advantage for your enterprise:
Your ERP system lacks the capability to effectively integrate mission-critical business data. Information silos increase complexity and ensure duplication of efforts, which compromises the quality, reliability, and accessibility of vital information.
Keeping your system updated has become costly and time-consuming. Has your system reached the point of diminishing returns?
Growing maintenance fees are eating your IT budget. Rising ERP solution maintenance fees increase your total cost of ownership over time.
You can’t easily access your data remotely. Cloud-based, mobile and social capabilities extend the power and reach of today’s ERP solutions – if your users can’t get to critical information from anywhere, you’re missing out on competitive advantage.
An upgrade would be disruptive to the business. Upgrades require time to plan and to execute. You’re in trouble if the business has to be ”down” for a period of time to do the conversion.
Suppliers and other trading partners can’t easily interact with your system. Today’s value stream is increasingly interconnected. You have to give your suppliers easy access to your orders and inventory levels.
Your system is not easy for today’s workforce to learn or use. Many older ERP systems are difficult to learn and workers are easily frustrated by instructions like “Press F1 to inquire” or “Press Enter to accept.” Today’s leading ERP solutions provide attractive, intuitive user interfaces that help users get up to speed fast and stay there.
Globalization is too difficult. Legacy systems often require you to run different versions to support various countries. This is not acceptable in today’s global marketplace.
Your company’s ERP system is a key part of your IT strategy. And, just as important, it is one of your most critical and sensitive corporate assets. When it comes to evaluating the future of your ERP system, you have three basic options: stay put, upgrade or replace you legacy system.
But any ERP investment decision requires careful consideration. Staying put seems like the low-cost option – unless your current system lacks capabilities the business needs to stay competitive. Upgrades can be expensive and time consuming, but they add business value by providing new functionality and improving business processes. Then again, sometimes the most strategic option is replacing the legacy system.
ERP systems typically have a 15- to 20-year useful life, but over that time they need to be maintained and enhanced to protect their value and serve the changing needs of the business. Because ERP systems help manage critical functions like accounting, inventory, manufacturing, sales, human resources and business reporting, companies need to plan for periodic updates to ensure the reliability and effectiveness of mission-critical applications. When ERP is integrated into other software such as customer relationship management (CRM), electronic data interchange (EDI) and business intelligence (BI), the result is highly complex and expensive.
When evaluating your ERP strategy and reviewing the options, take time to consider the following:
- Unmet business needs: Does your current ERP system support the business efficiently and cost-effectively? Are the system's capabilities adequate, or are they inhibiting the company’s ability to compete and grow? Are there significant internal control, process, supply chain, compliance or software integration issues?
- Return on Investment: What does the business expect to realize from its ERP investment? Is the current system putting the business at risk? Are you spending more than you should on maintenance? Would an ERP upgrade provide greater ROI? Can the company accommodate the time and cost of an ERP upgrade or migration?
- Organizational capability: Does your enterprise have the ability to take on a disruptive and costly upgrade or migration project? Is the right leadership in place to guide the company through the necessary procedural and organizational changes to gain the most from an ERP switch?
In the past few years, significant improvements have been made in the technologies and functionalities available with ERP systems. ERP deployment options like hosted delivery or software-as-a-service (SaaS) are reliable and cost effective, and make upgrading simpler and less expensive over time. Mobile ERP has evolved from its early adoption phase to a strategic performance enabler. Many companies experiencing improved financial performance following the worst of the recession are taking a fresh look at an ERP upgrade.
Whether you decide to stay put, upgrade or replace, make sure that you approach decisions about the future of your company’s ERP system strategically.
There’s no question that the new Medical Device Excise Tax (MDET) is going to involve cost, complexity and risk. Companies affected by the new MDET risk penalties, interest charges, additional transaction processing time and reconciliation costs to the extent that their systems and processes aren’t ready to cope with the regulation’s demands.
Fortunately, medical device makers with QAD ERP in place are in a better position to reduce these risks and meet the implementation deadline. Strategic has been helping medical device customers get ready to meet the implementation deadlines with minimum cost and maximum compliance.
MDET fast facts:
- In conjunction with the Affordable Care Act, the US Government enacted a 2.3 percent excise tax on the sale of taxable medical devices.
- The MDET, under Internal Revenue Code Section 4191, takes effect on January 1, 2013.
- The MDET is a manufacturers excise tax: The manufacturer or importer of a taxable medical device is responsible for reporting and paying the tax. The tax will attach at the point of sale from the manufacturer to the distributor.
- Companies will have to pay the tax on inventory on hand on December 31, 2012, that is not sold until January 1, 2013.
Which products are taxable? The new law provides that any device defined in Section 201(h) of the Federal Food, Drug, & Cosmetic Act (FFDCA) that is intended for humans will be taxable. The FFDCA is written very broadly to include instruments, machines, implants and in vitro reagents, among others. Section 201(h) also includes associated parts and accessories that are:
- Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them.
- Intended for use in the diagnosis, cure, treatment or prevention of disease or other conditions.
- Intended to affect the structure or any function of the body, excluding products relying on a chemical reaction within or on the body or being metabolized to achieve their primary intended purposes.
- Dental instruments, dental equipment, and research-use-only devices.
There are three major categories of exemptions:
- Devices to be further manufactured.
- Devices manufactured that are ultimately destined for export outside the United States.
- Eyeglasses, contact lenses, hearing aids, or “any other medical device determined by the Secretary as generally purchased by the general public at retail for individual use” -- referred to as the “retail exemption”.
How do companies pay the excise tax? IRS Form 720 must be filed each quarter in the month following the calendar quarter end. In general, however, MDET must be paid twice per month. Processes must also be established to handle registration requirements, exemptions and credit and refund issues.
QAD Global Tax Management is a module within QAD Financials that provides tax management solutions for excise, sales, use and VAT taxes globally, ensuring correct tax registrations and smooth tax reporting. QAD Global Tax Management provides:
- Global tax treatment for multiple tax environments in the same database
- Unlimited number of tax types and rates -- VAT, luxury, consumption/excise, capped, non-recoverable, sales.
- Consideration of geography; item status (taxable, non-taxable); customer/supplier status; effective dates
- Flexible reporting
- API into Vertex, AvaTax, Cytak and other state rate tax providers and filers
Strategic can help you leverage your QAD system to address these critical MDET details:
- The MDET applies to US-only sales; if your company sells to both foreign and domestic markets, this tax is only reported on your US sales.
- MDET is product specific; the system automatically flags applicable products. When invoices are made up of multiple line items, only flagged products are taxable.
- Sales to certain entities (e.g., non-profits) can be flagged as exempt.
- MDET is a Federal tax, however reporting by state is needed.
- Companies have the option to handle the tax on-invoice -- pass the tax to customers -- or off-invoice -- internal, accruing the tax based on calculations.
Process product returns and similar transactions accurately:
- When a product is returned and replaced with another, MDET is not paid on both products.
- When a product is returned without replacement, issue a tax credit to offset the original tax paid.
There are multiple approaches for using your QAD application to comply with the MDET, and we are available to help you understand which approach is best for your circumstances. Once you determine your strategy, we can also do the behind the scenes work to set up your system properly. If your QAD ERP interfaces with outside tax systems, we can help there too.
Medical device manufacturers operate in one of the world’s most highly regulated industries, where success can hinge on time-to-market, traceability, quality management and compliance with the latest regulatory requirements. Whether a company is a venture capital medical device start-up (VC medical device start-up) or a growth-oriented medical device company, it must follow closely controlled processes to develop and manufacture products that meet the strictest quality standards.
In order to fully manage quality and track all data related to all of their products across the entire supply chain, medical device manufacturers need ERP systems that monitor production, purchasing, documentation and traceability -- while cost-effectively managing compliance requirements.
An appropriate medical device ERP is a critical piece of an overall quality management system for medical devices (medical device QMS) that must be validated for regulatory agencies. U.S. Food and Drug Administration (FDA) 21 CFR 820 QMS requirements ensure product safety and efficacy. Good manufacturing practice (GMP) requires medical device manufacturers to apply relevant sections of FDA Part 820.
Medical device ERP software should help companies meet all FDA requirements for both software and operations. Manufacturers should look for comprehensive compliance monitoring, quality management (QM) and supply chain management functionalities.
The Top 10 things to look for when evaluating a new medical devices ERP system, such as QAD for life sciences, include:
- Ensure quality standards compliance such as TS13485 and ISO 9001
- Meet FDA software validation requirements
- Secure electronic signature and document control to comply with 21 CFR Part 11
- Complete visibility, control and audit trail of manufacturing processes
- Integrated Corrective Action/Preventive Action (CAPA) functionality
- Lot and serial tracking and traceability
- Warranty and service tracking
- Regulatory Compliance
- Supplier management/approved vendors
- Eliminate time-consuming, paper-based tracking systems
ERP Solutions for Life Sciences Strategic Information Group helps medical device companies leverage QAD ERP for life sciences, along with a full range of medical device solutions including ERP, CRM, and QMS. We help VC medical device startups commercialize and established companies reach their exit strategies, such as IPO or medical device company sale.
We serve medical device manufacturers in the Bay Area, Southern California, Boston and other regions across North America to help them meet the critical needs of Life Sciences manufacturers:
- Fully integrated business processes, including: Manufacturing, Financials, Quality, CAPA, CRM
- Support for GMP, SOX, FDA Regulations and FDA Software Validation
- Device and Batch History Reports and support for FDA audits/recalls
- Cradle-to-grave traceability, serial genealogy and controls for FDA CFR 11 and ISO3845
- Flexible and affordable deployment options including Cloud ERP and mobile access via iPad, iPhone, Android
Contact us today about our free ERP RFP template designed for the needs of Life Sciences companies.
Companies adopt cloud-based initiatives with the goal of creating a strategic platform to deliver increased profitability and customer value. As an application delivery mechanism, the cloud offers significant cost advantages. It can also pose some unique integration challenges. Whether cloud-to-cloud or on-premise-to-cloud, integration has a high impact on the overall success of any cloud-related initiative.
Integrating ERP and cloud applications improves efficiency and responsiveness. For example, integrating ERP and a cloud-based CRM like Salesforce.com enables employees to provide better customer service by putting the right information in front of them at the right time.
But in the rush to the cloud, companies all too often select and implement cloud-based applications without addressing integration ahead of time. Because integration is critical to the success of any cloud-based project, it should be part of the project plan from the start.
Companies need to recognize that integrating ERP and cloud applications requires a clear business vision and a sound plan. When technical parameters take precedence, business outcomes are often an afterthought. In fact, business benefits – like improved response time, improved data recovery, improved system congruence, more efficient order processing, and cost reduction – should be the starting point of any ERP-cloud application integration project.
Integrating ERP with cloud applications can be a resource intensive undertaking – but done properly, the long-term benefits far outweigh the up-front costs. That’s why it’s critical to get stakeholder buy-in in the initial phase, get business users and IT owners on the same page, and develop a detailed project plan for the integration.
Key considerations for a cloud-based integration plan:
- Set integration goals ahead of time
- Engage business and IT stakeholders
- Outline both business benefits and IT benefits desired
- Clearly define reference data; build a well-defined data architecture
- Determine data accuracy and timeliness
- Review security parameters and compliance requirements
- Select a technology to provide the most reliable, robust, and efficient communication
- Understand how integration may change roles, ownership and access
- Plan to communicate effectively with all stakeholders
ERP is complex by its very nature, with many potential stumbling blocks on the path to integration. Still, cloud integration is a simpler systems integration challenge than it used to be. Tool kits and repeatable adapters make integration much more stable and repeatable.
Organizations looking to integrate ERP and cloud applications like CRM should consider engaging an experienced partner that can guide the integration plan, manage stakeholder expectations and ensure that the integration produces the desired return on investment.
“Mobile” ERP has been around for a long time – for many years, users have been able to accesses ERP functionality via mobile devices designed for hard-working field services, warehouse or logistics environments. Fast-forward to today, and mobile ERP means access to the full suite of enterprise capabilities on personal mobile devices like tablets and smart phones.
More enterprises are examining whether mobile ERP on today’s consumer devices is merely "nice to have", or is becoming a strategic imperative. Taking ERP mobile on today’s devices – which were designed for consumer use, not business use – challenges companies to realistically examine and assess available capabilities, ROI expectations and actual costs before making the plunge.
Businesses, ERP vendors and device manufacturers are still struggling to understand how to effectively bring ERP onto today’s mobile devices. The ability to connect directly to existing functions and data turns a tablet into a true alternative to a laptop or desktop. But, without appropriate apps, tablets are useless as enterprise portals.
CIOs and other business decision makers also need to fully understand the impact of consumerization on enterprise mobility. Consumer technologies change often and require frequent upgrades. In addition, the mobile software itself needs to provide a look and feel that consumers are used to, while not confusing users. Because companies and ERP vendors want to simplify access to these systems on mobile devices, the end result may not resemble ERP access on desktops.
Unfortunately, many companies are investing in iPads without fully considering the upfront costs and ROI expectations. Others are pursuing a bring-your-own-device (BYOD) policy, opening the door to putting sensitive business information on employees’ personal mobile devices.
Enterprises considering a mobile ERP strategy should ask these questions:
- Are you focusing on devices and apps, while neglecting to create a true mobility strategy?
- What are the costs and ROI expectations of investing in company-owned devices vs. a BYOD strategy?
- Can your devices and apps adequately support a seamless experience from desktop to mobile device?
- Will the smartphone or tablet be an additional user interface, or a replacement for accessing the core system on a laptop or desktop?
- Have you considered how mobile ERP will integrate with your business, employees and customers?
- Are you prepared to create and manage a ‘mobile culture’?
As the mobile ERP trend develops, device vendors are challenged to step up their ability to deliver tools that are genuinely business capable. On the other hand, ERP vendors need to look at how they can simplify systems so they can jump from desktops to tablets and smart phones more easily. Business decision makers should carefully examine the costs and benefits of adopting a mobile ERP strategy.
It’s just evolving to meet the needs of your 21st Century business
Well, the “death of ERP” has been predicted for years now. But, like Paul McCartney, Madonna, and many others whose demises have been prematurely reported, ERP is still with us -- and just getting better.
A recent Forbes.com blog post on the topic claims that ERP was designed specifically for 20th century manufacturing businesses, and is too “rigid” to adapt to 21st century technologies and services-based business needs. The article states that today’s economy “demands new ways of both measuring and monetizing customer relationships. Companies must break out of the shackles of ERP if they are to succeed in this new world.”
The fact is, the established principles of ERP systems are being converted to new deployment methods like SaaS and the cloud, and to new devices like smart phones and tablets. ERP is rapidly evolving to emulate flexible, scalable subscription offerings like Saleforce.com and others. Rather than shackling businesses to antiquated models, today’s ERP gives companies greater freedom than ever to collaborate, communicate and leverage information for competitive advantage and bottom-line success.
Here are some of the big changes we are seeing in the ERP world:
Shifting to the Cloud Cloud deployment options change the dynamic for ERP. Subscription-based models are becoming main-stream, and private clouds are available for some ERPs. The primary benefit of the public cloud is mostly economical – small-to-medium businesses can save money, time, and physical space by using the hardware, infrastructure, and software of a third-party provider. The benefit of the private cloud is that you can use the same tools and software within your own datacenter or that of a third-party provider, with much more control.
Here Comes Social ERP Enhancing ERP with social media capabilities enables easy communication and collaboration both within an organization and between a business and its customers. Social media integration incorporates consumer-friendly social media tools alongside complex ERP applications -- ERP’s are even being designed with social in mind. Social ERP makes it simple for different departments to collaborate to use ERP data to improve customer service and company operations.
ERP Anywhere - Mobile ERP Mobile technology - including devices, software, networks and product distribution channels - accelerates and transforms business processes. As the technology has evolved, ERP providers have continued to adapt product development to deliver mobile capabilities. Today’s devices offer speed, convenience and unique capabilities to capture and respond to information in real time.
ERP for All The SaaS model makes it easy and cost-effective for businesses of all sizes to take advantage of the benefits ERP offers. Administration of ERP is usually entirely outsourced, letting them focus on their business. SaaS and cloud computing in general offer a deployment model that provides a predictable cost, scalability and straightforward upgrade path based on business value rather than technical obsolescence. Businesses with little or no network infrastructure and lean IT staffs can have fully functioning business software solutions that their employees can access from the Web, anywhere they happen to be.
An Engaging User Experience ERP developers are taking a cue from Apple and designing user interfaces (UIs) that truly enable user productivity. ERP sometimes gets a bad rap for static interfaces that focus on the data capture orientation of the most frequent users. Today’s ERP delivers UIs that focus on business outcomes, and extend the application reach to much more diverse array of user roles. These UIs offer rich graphical features that deliver business intelligence and interactive displays that enable decision-oriented activities and real-time customer interactions.
QAD Customers are invited to join us for a Customer Value Day at La Costa Resort near San Diego on Thursday September 27, 2012. Here are the top 5 reasons why you need to be there!
- Network with your peers
- Access to QAD executives
- Hear about QAD topics relevant to you!
- Learn about QAD's future roadmap
- Enjoy it all at the lovely La Costa Resort
View the Agenda Space is limited, sign up early!
A recent edition of Medical Device Daily featured reporting on yet another medical device manufacturer that received a warning letter from the FDA for serious violations uncovered during an inspection. One of the most serious red-flag findings in the warning cited that the quality system had “never been reviewed for suitability or effectiveness.” The warning also included a citation stating that the company did not have any procedures for medical device reports (MDRs). Sadly, the firm’s managers admitted that they were “unaware of the requirements of” the pertinent portion of the Code of Federal Regulations.
The violations cited in the warning letter spring primarily from this company’s QMS system, or lack thereof – but the story also points out the trouble a company can get into by not even knowing about pertinent regulation requirements. This also pertains to validating a company’s ERP system.
Another source reports that in the first three months of 2012, 35 life sciences companies received warning letters. 23 were sent to medical device companies; 14 of those were cited for corrective and preventive action (CAPA) or quality audit violations, and six for process validation violations.
The sad thing is that these violations and the accompanying consequences could easily have been prevented.
FDA violations can have serious ramifications, including seizure and injunction. Just as important are the losses in reputation, customer relationships and revenue. Across the life sciences industry, billions of dollars of revenue are lost each year due to companies taking a casual approach to FDA regulations.
That’s why a strong compliance program, supported by appropriate software applications, is mission critical for every life sciences company – from start-ups, to emerging companies, to established corporate behemoths.
At Strategic, we are in the business of helping our clients succeed – for our life sciences customers that also means implementing robust FDA compliance measures. While we can’t force a company to take appropriate action, we are very clear with our clients on the appropriate steps needed to comply with FDA regulations.
Strategic provides a full range of life sciences solutions – including ERP, CRM, and QMS – that provide an effective platform for growth and for meeting regulatory and compliance mandates. Just as important, our life sciences customers know they can rely on us as a trusted partner to not only deliver a comprehensive technology solution, but also to help them cover compliance risk.
We’ve got your back – don’t take any chances on becoming an FDA compliance statistic. If you have any questions about validating your QAD ERP, QMS implementation or review, support for GMP or other FDA-related issues, don’t hesitate to contact your Strategic account manager or call us at today at 760-697-1050.
Additional resources: Prepare for CAPA System Scrutiny In Device, Drug and Biologics Inspection; http://www.fdanews.com/prepareforcapa