This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


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 cloud with reduced risk of compliance:

  • Stay current in 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 prior to 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, 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 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 crossover 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 administration 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 in to 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’ own 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 engage 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 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 TV’s to cars are affected by the shortage of chips, which effectively function as the brain of electronics. To put it in perspective, Apple, the phone manufacturers 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, 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 policy makers. 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 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 own perspective. 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 he most favorable outcomes for business back home. Manufacturers want speed, efficiency, and capacity to deliver products to the hands of consumers. 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 process 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 are 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 an industry banks may not know enough about 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 re in high demand. There will certainly be 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 production and delivery of simple parts and components on a decent scale. You can send your CAD file direct to the 3PL, who will then print out the part and ship it directly.

For the recipient, potentially a manufacturer themselves 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 are able to achieve the quick turnaround they promise and meet 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 of 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, 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 Industry.


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


This page is currently only accessible to registered members of our website. Please register here to view this content. Thank you.

 


Encompass Solutions recently celebrated another successful go-live with a longtime partner and client. This company has several divisions, though this project took focus on Medical Device Manufacturing With Epicor ERP. The project focused on on-site locations in the United States and Costa Rica. The company’s primary Epicor team consists of three resources, supporting approximately 700 employees. The medical device manufacturing company utilizes several Epicor ERP components including all major modules, Advanced Material Management (AMM), Quick Ship, and Manufacturing Execution System (MES).

The Project

The project scope was to upgrade an existing Epicor 9.05.702a to Epicor 10.2.400. The upgrade project would also need to account for hundreds of custom BPMs, Dashboards, Reports, SQL Tools, and linked systems that had built up over the years. Additionally, a transition to an FDA validated environment with proper change control was necessary. All of this happened on a typical non-holiday weekend, with some manufacturing departments on-site and actively working.

The Encompass Solutions Team was responsible for:

  • Project planning and estimating
  • Project management
  • Technical assistance uplifting customizations, reports and dashboards,
  • Hardware configuration and sizing recommendations
  • All aspects of the data conversion
  • Conversion planning and preparation
  • System test planning

The Plan

An Encompass Solutions project manager was handed the sequencing and timing authority to map the timeline, deliverables, and overall upgrade project plan. At a high level, there were timelines created for Test Conversions, Technical Uplift Tasks, UAT, and Validation.

The project would follow Encompass Solutions’ standard upgrade methodology. This began by estimating the uplift effort, as that would drive the remainder the schedule.

The Execution

Once the project plan was established, Encompass and the client stood up the new 10.2.400 environment and performed the first pass conversion.

The next phase of the project, and most lengthy, focused on uplifting and unit testing over 800 objects (UI customizations, reports, BPMs, dashboard, and more)

Once the uplift was complete, a second pass conversion was performed. This served as the first conversion where we started to look at the length of the conversion, cleaning up errors and started to put together the conversion validation steps. This conversion served as the basis for system test.

System test planning started three months prior to the test. The actual test was conducted over a three-week period by the client and Encompass Solutions.

Upon completion of system test, we executed a third pass conversion.  This served to further test our conversion process and procedures. This also provided a clean database for the client to perform their validation process as required by the U.S. Food and Drug Administration. After FDA validation was complete, we executed a fourth pass conversion to finalize all conversion weekend steps, processes validations, timing, and reconciliation.

As part of planning, a series of test and practice installs took place prior to Go Live. During the weekend of Go Live, the project was within15 minutes of the anticipated Go-Live time. Encompass was onsite for the event, and post-Go Live, as needed.

“Perhaps the most surprising detail was that [Encompass] have taken ownership of most errors and bugs and seen them through resolution, which takes a lot of work off our team.”

– IT Business Analysis Manager

The Results

Go live was a smooth process. The client was able to successfully make jobs, ship parts, and collect payments. Aside from a few hiccups, 90% of the users are having a better experience with the updated Epicor ERP system. Of the 10% that didn’t have as great of an experience, these were mostly due to changes in behavior from Epicor 9 to Epicor 10, almost all of which were discovered during UAT. This means that during Go-Live there were very few surprises.

Next Steps

The company’s next steps including taking the Epicor 10 foundation and expanding it to two more locations in 2020 and a third in 2021. The client has already invited the same Encompass Solutions project team to assist in those future projects.

Encompass has also been engaged to support projects that will provide order integration with the client’s European operations, implement a vendor management inventory solution, as well as bring additional sites onto Epicor ERP.

Company Details

  • Established: 1999
  • Location: USA, Costa Rica
  • Industry: Manufacturing, Medical Devices
  • Previous System – Epicor ERP 9.05.702a
  • Current System – Epicor ERP 10.2.400
  • Deployment – On Prem

About Encompass Solutions

Encompass Solutions, Inc. is an ERP consulting firm, NetSuite Solution Provider and Epicor Gold Partner that offers professional services in business consulting, project management, and software implementation. Whether undertaking full-scale implementation, integration, and renovation of existing systems or addressing the emerging challenges in corporate and operational growth, Encompass provides a specialized approach to every client’s needs. As experts in identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of Industry.