Medical Device manufacturers are under constant pressure to ensure they are delivering parts on time, and of the highest quality. To further challenge the industry, Medical Device manufacturers must comply with both their customers and the industry regulators’ stringent requirements. These pressures are driving medical device manufacturers to look for new ways to reduce costs, improve quality, and become more efficient on the shop floor.

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


High-growth Medical Device companies are always looking for ways to accelerate innovation across the product lifecycle to support patient needs. They are also seeking to improve product quality and manage costs to support financial growth.

Until recently, companies have gad to implementing multiple on-premise point solutions, such as ERP, PLM, MES, and QMS to achieve these goals. Today, these Medical Device organizations are looking for enterprise-wise, cloud-native platforms that support improved outcomes across the entries product lifecycle.

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


To compete, manufacturers in regulated industries need to be agile and innovate at a high velocity. Epicor® ERP is a leading manufacturing platform for life science manufacturers as it offers the product traceability, system controls, and more needed to respond to your growing business while allowing you to meet regulatory challenges. The availability of critical business systems in the cloud improves your ability to compete. Cloud enables both business agility and the increased speed at which technology is delivered to better meet business needs for innovation. Additionally, the Epicor ERP Cloud Validation Bundle for Life Sciences offers a cloud solution designed to reduce the risk of compliance with support for the software validation needs of FDA-regulated businesses.

Epicor ERP Cloud Validation Bundle Benefits

As a Life Sciences Manufacturer, take advantage of the benefits of the cloud with reduced risk of compliance:

  • Stay current in the cloud with an annual upgrade cadence for extended validation testing and documentation.
  • Ensure your business is ready for every upgrade by leveraging customer-proven best practices that minimize disruption.
  • Meet demands for high growth with flexible cloud solutions, easily scalable and adaptive to current and future business needs.
  • Drive strategic business outcomes with an Epicor ERP Cloud system to better align with your organizational goals.

FDA 21 CFR Part 11 Compliance Requires Validation of Software

Companies must validate that the software and systems used to create and maintain electronic records and signatures can ensure the integrity of the electronic results and information. This is done through software validation. The guidance offered by the FDA for software validation is in terms of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The Epicor ERP Cloud Validation Bundle for Life Sciences supports IQ documentation on your Epicor cloud solution to supplement IQ documentation for internal systems within your validation plan.

Validation Documentation Available with the Bundle

The Epicor ERP Cloud Validation Bundle for Life Sciences supports IQ documentation on your Epicor cloud solution to supplement IQ documentation for internal systems within your validation plan.

Note: You are responsible for IQ validation documentation and testing of any installed software and devices at their location. Also, as you are responsible for your validation state, Epicor makes our documentation available for review. The following reports are available:

  • Epicor ERP IQ Software Validation Plan (VP): VP-01
  • Epicor ERP IQ Software User Requirements Specification (URS): URS-02
  • Epicor ERP IQ Software Risk Management Plan (RMP): RMP-03
  • Risk Assessment / Failure Modes and Effects Analysis (FMEA): FMEA-04
  • Epicor ERP IQ Software Risk Management Report (RMR): RMR-05
  • Epicor ERP IQ Software Functional Requirements (FR): FR-06
  • Epicor ERP Installation Qualification (IQ) Software Validation: IQ-07
  • Epicor ERP IQ Software Validation Summary Report (VSR): VSR-08
  • Epicor Managed Hosting SOC 1 Type II Report
  • Epicor Cloud ERP SOC 2 Type II Report
  • Epicor SOC 2 Bridge Letter

Cloud Elements of the Bundle

The solution is a bundled offering that comprises the following cloud elements:

  • Epicor ERP Public Cloud U.S. Government Option
  • Epicor Public Cloud Validation Environment with Public Cloud Premium for your dedicated validation testing
  • IQ documentation and audit inquiry support in the event of customer or FDA audit
  • Extended validation cloud cadence of one year to provide additional time for validation documentation and testing

Epicor ERP Cloud Validation Bundle for life science and medical device manufacturing environments

Figure 1: Epicor ERP Cloud Validation Bundle for Life Sciences. Note the solution is available in Azure Government Cloud and that additional environments are available but must be enhanced with a corresponding Premium Pilot Extension to match your solution set.

Cloud Upgrade Cadence for the Epicor ERP Cloud Validation Bundle for Life Sciences

Supporting the needs of the life sciences business with a software upgrade cadence that delivers time for added testing is built into the solution. Users will have stages for planning, validation testing, reporting of issues that impact validation, and regression test time for their validated processes. They will also need to test their non-validation processes such as financial transactions. Below is a diagram that outlines a sample cadence for the solution. In addition to a one-year cadence for major releases, the solution will offer a quarterly update that is made available in the pilot environment the month before making it available in the live environment.

Epicor ERP Cloud Validation Bundle for life science and medical device manufacturing upgrades

Get Started With Epicor ERP Cloud Validation Bundle

Business leaders balance the pace of business innovation, fluctuating demand, and regulatory compliance requirements when deploying new technology. Reducing the risk of change in these environments provides greater business resiliency with the added benefit that the cloud delivers, including the ability to stay current with technology to drive greater results. Epicor uniquely understands the needs of a life sciences manufacturer with cloud-based ERP. You need the flexibility and control to run your business your way while benefiting from the cloud technologies and business models that fit.

About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


Manufacturing has had one wild year and, in the wake of COVID-19, many industry experts, boardroom executives, and men and women on the production floor are “shopping” their theories for 2021 manufacturing trends.

Theories for what 2021 will hold run the gamut, but there is plenty of crossovers shared among contributing voices. Here are some of the most often mentioned subjects we are sure will emerge as the most impactful 2021 manufacturing trends.

The Reshoring of Manufacturing

When the mechanisms of manufacturing all but ground to a halt in Q1 of 2020, it became vividly apparent just how dependent nations were on the capacity and capabilities of a select few manufacturing powerhouses. A year on and COVID scarcity has driven the prices of raw materials up 100-200% when compared with the same period last year.

In the wake of this glut, more than one-fifth of US manufacturers surveyed by BDO are committed to the reshoring of operations as a top priority in 2021.

While both the current and previous administrations are pushing for consumers to “Buy American”, the same sentiment is ringing loud and clear through the EU, Japan, South Korea, and many other leading nations.

The world bought cheap and abundant labor out of China for decades, which left supply chains around the world bottlenecked and vulnerable. Today, diversification of the supply chain is widely regarded by manufacturers as a must-have, and countries like Vietnam, Thailand, Malaysia, and Mexico are raising their hands to offer the capacity and talent to meet the needs of more local-focused supply chains.

Addressing The Education And Skills Gaps In Manufacturing

With decades of reliance on external manufacturing capacity, US-based manufacturers have seen an ever-increasing skills gap needed for their operations at home.

A tremendous contributing factor is the perception of manufacturing as a Triple-D sector. That is, dirty, dangerous, and dull. Whether on the shop floor or at the engineering desk, manufacturers are struggling to fill a gap in skilled jobs that Deloitte expects to reach nearly 2.5 million positions by 2028. Fortunately, according to the National Association of Manufacturers (NAM), manufacturers are willing to pay to close that gap.

Chad Moutray, NAM Chief Economist, said “Manufacturers consistently cite the inability to attract and retain talent as their top concern, and as this survey underlines, they are taking strong proactive steps to overcome it.” The Institute surveyed US manufacturers on their spending in the sector, which totaled more than $26 billion targeting training programs for new and existing employees.

Trade schools, analytics, sensor technology, robotics, AI, VR, etc. are garnering considerable investment to draw in the talent required to fill the deep need these manufacturers are experiencing.

Experts say that simply throwing money at the problem is not enough. Manufacturers and institutions need to share in the investment and collaborate to ensure that what students are learning now is what will be relevant in the manufacturing sphere by the time they graduate.

Talent simply cannot be trained to meet the needs of businesses because tech is changing at such an exponential rate. Agreements between schools and manufacturers will have to provide work experience opportunities while studying to close the gap.

In Encompass’ backyard, Guilford Technical Community College has received both considerable financial investment and buy-in from regional manufacturers with the institution’s recently opened Advanced Manufacturing Facility in Jamestown, NC. There is just as much investment from other manufacturers around the country who are hungry for an engaged and talented workforce produced locally.

Global Shortages Of Computer Chip Manufacturing Hit Home

With climate change, a topic of ongoing significance globally, the reliance on regionally produced tech has put the entire world’s supply of computer chips on thin ice.

Regional environmental conditions are now playing a much larger part than before in how we view the risk associated with the supply chain. For example, the majority of the world’s motherboards are manufactured in Taipei, Taiwan. This region is categorically prone to massive and disruptive weather events and earthquakes. For decades, this has been a reality the US, and frankly, the rest of the world accepted as part of navigating a global supply chain.

Initially, when the coronavirus pandemic first hit, semiconductor factories shut down, causing delays in the supply chain. Because it can take up to several years for these factories to reach their previous production levels, the shortage will likely persist for some time.

Everything from TVs to cars is affected by the shortage of chips, which effectively function as the brain of electronics. To put it in perspective, Apple, the phone manufacturer with a $2 trillion value and semiconductor budget of $58 billion annually, could not get enough of these in-demand chips for their iPhone 12 launch last year. The result was a two-month delay and things are only getting worse for manufacturers big and small.

According to Mirabaud tech analyst Neil Campling, “There is no sign of supply catching up, or demand decreasing, while prices are rising across the chain. This will cross over to people in the street. Expect cars to cost more, and phones to cost more. This year’s iPhone is not going to be cheaper than last year.”

Med Device And Pharmaceutical Manufacturing Look Pale

Such supply chain bottlenecks as mentioned above exposed overreliance on external manufacturers of pharmaceuticals and medical devices over the last year, as well.

Supply chain resiliency, through redundancy and duplication, is a costly and time-consuming effort. However, manufacturers are increasingly adopting a shift in thinking to ensure they can avoid the pitfalls COVID-19 has exposed.

Many medical devices and pharmaceuticals are only sourced through specific geographies. As a result, strategic goods and services will need to be tackled first in a new wave of focus from US manufacturing industries and policymakers. Luxury and consumer-driven products will have to take a backseat until those top-shelf items can be secured at home.

Shifting Trade Policies From Corporate To Congress

US manufacturers are driving the demand for diversity in a capacity beyond East Asia. However, many of the west’s manufacturers, big and small, are making moves to end reliance on the East Asian manufacturing hubs. Recent upsets in trade policy, like free trade agreements, Brexit, tariffs, the repositioning of NAFTA, etc. all impact these efforts.

While not directly parallel, policymakers and legislators are approaching the problem from their perspectives. Regulators’ opinions on the evolution of the supply chain are translated through a different lens than manufacturers. Geopolitical relationships and national security may not translate into the most favorable outcomes for businesses back home. Manufacturers want speed, efficiency, and capacity to deliver products to the hands of consumers. The government will view its priorities through a different lens.

Digital Taxation and Role Reversal

As the border between big tech and manufacturing become more blurred, digital taxation and who does what are the new hot topics. With an increase in digital cross-over into the material realm, the mechanisms of how to handle taxation have not quite caught up.

Namely, this involves the lines between tech and tangible and where the border between industries is truly defined. Perhaps the broader question is, can it be defined?  With companies like Facebook, Google, Apple, and others, who traditionally created digital products, now constructing marketplaces, and investing in tangible goods, like autonomous vehicles, are they considered the new pioneers in manufacturing?

Where does that leave traditional processes and discrete manufacturers? As discrete manufacturers create IoT and IIoT solutions to complement their tangible goods, like sensor and overall equipment effectiveness (OEE) software, do they share the profile of Big Tech? The waters grow muddy. One thing is for sure, the landscape of both tech and manufacturing is sharing more overlap than ever before.

Access to Cash and What it Means for SMBs

Borrowing and access to capital is a defining issue for smaller manufacturers. With interest rates low for manufacturers, questions about effective tax rates, trade relationships, and capital expenditure have been conservative. Fortunately, trade talks with the Biden administration and China have started to take shape, vaccinations are rolling out, and outlooks are generally optimistic.

One leading indicator of this upward trend is found in the number of bankruptcies experienced by manufacturers over the last year. Not nearly as many bankruptcies emerged as were predicted by researchers, analysts, and economists. The big change may have been the fact that banks do not want to become owners like after the 2008 housing crisis. There is simply too much to manage in manufacturing and rather than take on the headache of industry banks may not know enough to run effectively, they opted to work with businesses in the sector to find solutions that worked for both sides.

Robotics and Automation

Robots and automation have been four-letter words for decades, essentially scaring people away from manufacturing. Unfortunately for fear mongers, the need for skilled labor is even more necessary with the inclusion of these advanced technologies. More engineers, more cobot operators, maintenance personnel, and even truck drivers to fuel the internal distribution networks of the United States are in high demand. There will certainly be an upset in the world of manufacturing as these technologies proliferate. However, the timeline by which that proliferation overtakes a human workforce grows ever longer as technology proves to be just as reliant on us as we are on it.

The New Contract Manufacturers

New methods of manufacturing, such as 3D printing or additive manufacturing, are upsetting the traditionally held roles in Industry.

Take, for instance, the effect these technologies have bestowed on traditional distributors.

Third-party logistics providers (3PLs) like Fed Ex, UPS, and others are entering the manufacturing arena, cutting out a space for themselves, and cutting off competitors, in some cases manufacturers, by assuming certain aspects of manufacturing. By leveraging additive manufacturing technology, these logistics providers can cut out the middleman to handle the production and delivery of simple parts and components on a decent scale. You can send your CAD file directly to the 3PL, who will then print out the part and ship it directly.

For the recipient, potentially a manufacturer, in this case, there is a degree of control that is relinquished. Depending on your product, at some point, you will need to verify that your vendor (3PL) is meeting your quality requirements. While the approach is in its infancy with a foundation shaky enough to keep some at arm’s length, it could be a trend that picks up steam quickly. If these providers can achieve the quick turnaround they promise and meet the quality standards that manufacturers and consumers demand, there could be a real shift on the horizon.

Green Materials Propagate in 2021 Manufacturing Trends

Sustainability has never been a topic weighing as heavily on consumers’ hearts and minds as it is today. This puts more weight squarely on the shoulders of manufacturers.

If consumers want more environmentally conscious products and production methods, it’s up to manufacturers to adapt and educate their customers about the changes taking place.

Take for instance the textiles and plastics being replaced by renewable and eco-friendly materials, like mycelium.

Major global brands like Dell Technologies and IKEA have already committed to adopting a Styrofoam packaging replacement made by Ecovative Design.

Indonesian manufacturer MYCL will soon launch a series of sneakers, sandals, wallets, luggage tags, and watch straps made of its mycelium-based leather, Mylea.

The trend has even proliferated into the world of high fashion, with U.S. manufacturers Bolt Threads and MycoWorks aiming to make mycelium-based leather products more widely available this year.

About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


Imagine what you could do with instant, accurate machine data and process information directly from the machine. Even depth and dimension are within reach with the help of a manufacturing execution system (MES). Medical parts, supply, and equipment manufacturers use MES for real-time production monitoring and analysis to improve throughput, boost quality, and reduce scrap. You can achieve more capacity with the same machines and improve overall equipment effectiveness (OEE)—working more efficiently and profitably. This white paper highlights four ways to boost your performance with the right manufacturing execution system.

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


The Food and Drug Administration’s Code of Federal Regulations Title 21 Part 11 (FDA 21 CFR Part 11) helps streamline compliance with a wide range of FDA regulations by supporting FDA-regulated industries in their efforts to submit necessary documentation in an electronic format. In particular, 21 CFR Part 11 provides regulations that enable manufacturers to use electronic records and signatures in a manner equivalent to paper-based records and handwritten signatures.

This regulation specifies that to use electronic records and signatures, companies must meet four conditions. They must validate the software and systems used to create and maintain electronic records, provide secure access to those records to maintain confidentiality and data integrity, hold individuals accountable for their electronic acts about electronic documents, and ensure that electronic signatures cannot be repudiated. However, the FDA does not specify how companies must address these requirements—rather it provides a set of guidelines based on common sense and good workflow processes.

This whitepaper describes the requirements for FDA 21 CFR Part 11 compliance at a high level and discusses how Epicor enables FDA-regulated manufacturers to fulfill these demands. Because Epicor builds the necessary capabilities into its products, implementation is fast, easy, and comprehensive.

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


Kinematic has been a global supplier of automated manufacturing systems for the medical industry since 1980. The company develops small to large-scale custom, state-of-the-art manufacturing systems built to the exacting standards and strict compliance requirements of the medical and diagnostic industry, and utilizing the tenets of lean manufacturing. Capabilities include all aspects of machine design and development, fabrication, assembly, and testing, as well as machine installation, operator training, and maintenance.

Success Highlights

Challenges

  • Needed strong manufacturing ERP capabilities to support its low-volume build-to-order production environment
  • Desired real-time data access to improve efficiency, collaboration, and overall responsiveness
  • Needed to be up and running in a compressed five-month timeframe

Solution

  • Epicor enterprise resource planning (ERP)

Benefits

  • Improved functionality and easy-to-use user interface offer immediate access to data
  • Improved accuracy, collaboration, cycle times, and on-time delivery
  • Improved efficiency enabling the ability to support greater production volume with existing resources
  • New robust reporting capabilities enabled the retirement of the custom reporting system

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, and renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


Proton therapy is a highly advanced, painless, and precise form of external beam radiation that has been used to treat 100,000 cancer patients worldwide. An exceptional option for childhood cancers, it has also become ideal for treating solid tumors of the prostate, brain, eye, head, and neck, inoperable small cell lung cancer, as well as liver and certain types of breast and gastrointestinal cancers.

Optivus Proton Therapy, Inc. (Optivus) was launched in 1993 by the center’s original engineering team led by Jon W. Slater and entrusted with the entire facility’s technical enhancements and ongoing maintenance. Founded on the principles of continuous excellence, Optivus has developed and implemented hundreds of design and new technology improvements over the past two decades according to the facility’s precise clinical specifications.

Success Highlights

Challenges

  • In addition to manufacturing, Optivus is a project-driven organization, with significant requirements for tracking hundreds of thousands of labor charges and managing a bill of materials with thousands of parts

Solution

  • Epicor® ERP

Benefits

  • Better understand job costs through the generation of detailed records integrating manufacturing and engineering with payroll and accounting
  • Identify the exact location and status of parts stored across four separate warehouses
  • Create purchase orders with detailed line items attributed directly to project steps
  • Readily reconcile accounting differences between purchasing, receiving, and billing

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, and renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


SHL Group (Scandinavian Health Ltd.) is currently the world’s largest privately-owned designer, developer, and manufacturer of advanced drug delivery devices. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson, to combine world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures medical devices that include pen injectors, auto-injectors, and inhaler systems. SHL also makes a range of other products, including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters, and industrial equipment.

Success Highlights

Challenges

  • To successfully unite the global development teams with manufacturing in Asia, and promote precise data integration across the entire enterprise, as well as efficient, informed communication and decision making across the entire group structure, in three languages, in three countries, and in three continents

Solution

  • Epicor ERP

Benefits

  • Facilitates speedy cross-regional communication and data integration
  • Increased business efficiency
  • The ability for management to make informed decisions faster
  • Enhanced business competitiveness

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, and renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.


Centor is the world’s largest supplier of regulatory-compliant prescription containers for medication dispensing. The Berlin, Ohio plant manufactures plastic prescription pill containers and plastic packaging for liquid products and it is using Epicor Mattec MES—the Epicor real-time production monitoring and manufacturing execution system.

Success Highlights

Challenges

  • Institute a standardized system of reporting and data collection for more advanced insight into the production process

Solution

  • Epicor® Mattec MES

Benefits

  • Improved production and process control for better decision making
  • Increased machine efficiency with standardized OEE reports
  • Improved quality control and operations

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, and renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.