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.


When it comes to medical device manufacturing, the FDA has maintained rigorous standards for manufacturers to satisfy. Traceability, quality management, and reporting are among the many areas in that manufacturers need superior performance to meet those standards. The FDA’s push for digital means of achieving and providing a record of how standards are met has many businesses looking to ERP software for medical device manufacturing.

Fortunately, ERP systems have been delivering on these demands and more for decades and are suited to meet the changes in regulatory environments. Such powerful systems help to increase the reliability of processes and reduce instances of failures, recalls, and corrective actions. Not only this, but the benefits of ERP make maintaining compliance and records easier and more cost-effective.

The Benefits Of ERP Software For Medical Device Manufacturing

When it comes to the requirements placed on manufacturers by the FDA, it’s easy to see why ERP is increasingly being leveraged to reduce the difficulty in meeting those obligations.

Data is available at every turn in the manufacturing process and ERP systems can help medical device manufacturers leverage that data in the validation process. This data enables management regulatory obligations, optimization of manufacturing processes, and the resulting increase in customer satisfaction. ERP systems capture this vital information to lessen the risks associated with compliance standards and turn efficiency concepts into real-world results with ease.

How Medical Device Manufacturers Use ERP

Compliance is the top motivator for adopting ERP software for medical device manufacturers. FDA regulations, as well as those for international regulatory bodies, are constantly evolving alongside new technologies, products, and research. ERP provides a means of establishing protocols and processes to satisfy the latest regulations at every stage in the manufacturing life cycle.

Accessibility is another important factor driving the adoption of modern ERP systems. Whether in the board room or on the shop floor, teams need the latest data and documentation to make informed decisions, in real-time. Legacy ERP systems lack the connectivity to this data that modern, cloud-based ERP systems provide. Even sales teams on the road require such access when a customer wants to know how a manufacturer’s products conform to the latest regulations, as well as the proof to back it up.

Auditing is a process required both internally and externally for medical device manufacturers. Audits may be scheduled or conducted at random. In any case, a manufacturer wants to know if they can retrieve and report data on every process in the manufacturing life-cycle. ERP software provides all that in a centralized and secure location.

The tracking and traceability ERP software provides will ensure that each stage of the manufacturing process comes with oversight. Easy-to-follow audit trails streamline the process and identify where, when, and how problems emerge. Recalls, while never an easy process, are swift and efficient thanks to ERP software that leverages automated lot and serial tracking to keep customers safe and businesses insulated from risk.

Through automation, manufacturers can remove the manual tasks associated with logging data, such as billing and manufacturing execution. This cuts down on human error that causes most delays and downtime in manufacturing and sales cycles. While not necessarily a matter of regulatory compliance, the efficiency ERP software provides in this regard only strengthens the case for its adoption.

FDA Requirements Of ERP Software For Medical Device Manufacturing

The electronic records and signatures requirements set by the FDA are stringent and any system of manufacturing must comply with the regulations to receive approval. The full body and outline of these regulations as they relate to ERP software for medical device manufacturing can be found in 21 CFR part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES:

Subpart A-General Provisions 
§ 11.1 – Scope.
§ 11.2 – Implementation.
§ 11.3 – Definitions.

Subpart B–Electronic Records 
§ 11.10 – Controls for closed systems.
§ 11.30 – Controls for open systems.
§ 11.50 – Signature manifestations.
§ 11.70 – Signature/record linking.

Subpart C–Electronic Signatures 
§ 11.100 – General requirements.
§ 11.200 – Electronic signature components and controls.
§ 11.300 – Controls for identification codes/passwords.

and 21 CFR §820 regarding quality:

PART 820—QUALITY SYSTEM REGULATION

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 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 the Industry.


Medical device manufacturing has grown more and more complicated as products become more intricate and regulators become stricter about conformity to rigid standards. These two industry trends have driven Medical Device Manufacturing ERP systems to command an increasingly larger portion of the conversation on where the industry is headed.

an image of items that can be created through medical device manufacturing erp with encompass solutions consulting services

Medical Device Manufacturing ERP And Encompass Solutions 

As a result of the growing trend, Medical Device Manufacturing ERP implementations and integrations into existing business systems are in high demand. But that doesn’t mean all implementation specialists are created equal. Encompass Solutions delivers proven implementation and consulting experience to an array of medical device and bio-science clients. The longstanding partnership with ERP vendor Epicor has kept Encompass at the forefront of ERP and manufacturing industry developments.

What A Medical Device Manufacturing ERP Can Do For You

The platform allows all facets of the business to derive data from a single source. Epicor ERP allows users to control accounting, production, forecasting, performance metrics, product lifecycle management, 360-degree visibility, and much more. Encompass Solutions empowers clients with the training and support to utilize these powerful tools to their fullest extent in heavily regulated markets like medical devices, aerospace and defense, and aviation.

Whether a medical device manufacturer is regional, national, or international, the same essential tools can be leveraged to manage quality, meet demand, and facilitate the corporate and operational growth of their organization. Automating manual and non-value-added back-office tasks with an ERP system will provide talented staff to take on more value-added tasks, such as customer care, and sales, and ensure conformity to government and industry standards.

Encompass Solutions Is Your Medical Device Manufacturing ERP Partner

Encompass clients utilizing medical device manufacturing ERP systems work with our consultants regularly to automate manual tasks, improve processes and maintain their organization from the shop floor to the top floor with less effort and fewer costs.

Our position as subject matter experts ensures that clients not only have a partner that speaks their language but can value-add to their organization for the lifetime of their partnership. From implementation, to upgrade, and beyond, you bring the vision and bring the tools with business systems to fit the build.

About Encompass Solutions

Encompass Solutions, Inc. is an ERP consulting firm 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 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 the Industry.