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cGMP Compliance & ERP

cGMP Compliance & ERP

What is cGMP?

cGMP stands for current Good Manufacturing Practice and, more than just initials, it is at the center of the US Food and Drug Administration’s efforts to protect citizens from potential hazards related to food and beverages, cosmetics, pharmaceuticals, and medical devices. ERP is the system used by businesses for accounting, inventory management, sales order processing and many other processes central to maintaining management control. ERP is where businesses keep the records that show they are complying with good manufacturing practice.

cGMP Compliance ERP

What does cGMP look like for manufacturers?

Process Control

Process control is critical in these controlled industries. We need to define exactly how our product flows through manufacture. Who will perform the necessary manufacturing steps? What ingredients or component parts are required? When does each step take place related to the previous and following steps? Where will we manufacture our products – in which facility and using which equipment? Why are we taking these measures to control our process? How will we document exactly what we did and compare it to what we said we would do?

Training

An ERP system has a record of each employee. That record goes well beyond payroll and human resources. If we add the training each person has had and their current work qualifications, we can use ERP to work with our cGMP process. We can now schedule specific people within our overall production schedule. The people scheduled are limited to only those who have required training and certification based on the rules we established within our business. Next we can use ERP to track exactly who worked on each manufacturing step. This enables us to pass any audits. We also now can know who might have made any error or failed to precisely follow our defined process.

Compliance Department

Inventory

Our cGMP includes a specific list of ingredients or component materials required to produce our product. Our list can further limit the materials used to those from specific suppliers or items commonly available from multiple sources. ERP helps us track each item by lot number so that we never inadvertently mix a lot in the same batch. Lot tracking sets up our ability to manage any potential recall. We know which output batch had an issue and know exactly which ingredient lots we used in that batch. We can also use ERP to avoid any chance of using an item beyond its shelf life.

Recipe or Routing

ERP provides us with the manufacturing path that we know meets cGMP. Step one is performed on certain equipment and specified operations must take place then. We can measure the outcome of step one and ensure production is ready for step two. Since we know the duration of every step, we can schedule equipment and personnel and provide the completion date and time for our customer.

Facilities and Equipment

Our cGMP specifies that products must be made only in approved manufacturing facilities and then only using specifically approved equipment within those facilities. The production schedules we use from ERP will use those limits and help us manage capacity requirements now and in the future. Manufacturers must identify what hazards might exist and establish control points best suited to capture and control those hazards. This requirement is known as HACCP or Hazard And Critical Control Points.

Testing and Measurement

Throughout the cycle of production, we will test and measure the product using values stored in the quality module of our ERP system. The tools we use are maintained and recalibrated as we define in cGMP and our test results include the specific tools used as well as the results. Testing and measurement looks for statistically significant variances and enables us to determine corrective and preventative actions and track those to completion all within our ERP.

Quality Management System

cGMP requires that we have an active quality management system that is fully documented. ERP is one of our primary record keeping tools and supports cGMP fully. Any business whose activities fall under the cGMP rules of the FDA should ensure their ERP fully supports their required control systems.

Are you facing ERP cGMP regulation challenges?

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Partnering with your ERP Consultancy

Partnering with your ERP Consultancy

How the Right ERP Consultancy Can Take the Risk Out of ERP Implementation

Implementing ERP presents many challenges. One of these involves the simple dilemma of finding good help. Implementing ERP is not a one-man band, but rather a symphony of interconnected members, each doing their part in the performance. Your ERP consulting partner is one such member of the overall team and can significantly impact the success of an ERP implementation. With that in mind, here are a few considerations that will help you make the best choice when finding a consulting partner.

ERP Consultancy Partnership Meeting

An ERP Consultancy Provides a Path of Success

Scope

At the beginning of your project, define what completion is and how to objectively measure the project’s completion. That definition might evolve as the project moves along, but it’s helpful to define your destination before you embark. This helps you understand how long you will need consulting assistance — completion means the consultant can move along to their next client. You will need to write that final check. Completion also means it is time for you and all the people in your enterprise to sit back and smile. Plan for that success.

Requirements

Consider the needs of your organization and the expertise you already have within your business. You might have a person you think is ready to lead your project: they have the skills and training, but a consultant could guide them and provide experienced mentorship along the way. Or, you might have a very lean organization and need to use a consultant as a full-time manager of the project and then plan to cut the consultant loose when the project is complete.

Culture

Culture is a very important consideration. The consultant who is successful working with a strict top-down leadership style will be different from a consultant who would succeed in an environment where each manager is independent and is expected to make decisions on their own. Your consultant must fit into your existing style and work well with your personnel.

Business Interaction

Negotiations with your consulting partner will begin with senior members of that organization. Those people might not be the same people who will actually work at your business with your own employees. Part of your agreement with the consultant should be control over consultant staff and their ability to get along with your employees.

Logistics

Provide your consultant with access to your systems, a place to sit, and an open communication line to everyone. Introduce the consultant to your staff and let people know who they are and the important work they will be doing on your behalf. Reinforce the call to open communications as needed throughout the project. Many ERP projects are a means of providing tools for future expansions or other plans that likely are confidential. Ensure the consultant understands and has signed appropriate non-disclosure agreements.

Change Management

You will hire a consultant that has the expertise to work with your business eventually to a successful completion of your ERP project. The relationship is not entirely technical. Your employees and system users all react to change in their own unique ways. Some will adapt quickly and embrace the new processes. Others will fight to keep the old process they are already comfortable using. Most will fall somewhere in between, neither fighting change nor immediately accepting change but will, in the end, use your new ERP system. A few might never accept the changes and will part from your business.

Managing change and helping your people along is one of the critical components of your ERP project. The ERP consultant you hire probably has the expertise you need in this area and you should take full advantage of it so your people can stay satisfied.

Data Management

Part of the ERP project will be data conversion from your legacy systems and loading that data into the new ERP. Many IT staff do not have the bandwidth to handle this work in addition to their current jobs. Often this work will be managed by your consultant. Consider who will handle data not only during the project’s duration, but also who will pick up the responsibilities thereafter.

Verification

As the project moves along, you will test specific transactions and the overall system to ensure the results meet your needs and expectations. Use your own people for some of the manual tests. Not only will they help with the project step, they will gain some training and become ambassadors representing all of your ERP users. The consultant will be a guide to setting up and managing testing. The consultant might have automated test processes too which will perform tests that follow your processes and repeat tests 24 hours a day. You will gain many additional test cycles and avoid human errors in testing.

Training

Think about how to train your people to use ERP when the project is complete. You can train a few to train the many and use your existing resources. You could also use the consultants to design and implement needed ERP training for you and your team.

Collaboration With Your ERP Consultancy of Choice

Fundamental to the idea of ERP is the notion of collaboration. Enterprise applications build bridges within the enterprise, and between the enterprise and the outside world. The act of implementing ERP is similarly an act of collaboration. In this light, when choosing a system integrator, ensure that they are an implementation partner, and not merely a consultancy for hire — for it is through people and partnership that the true benefits of ERP are realized.

Want to learn more about how an ERP consultancy can help your business?

3 Things to Consider When Upgrading From Epicor 905 to E10

3 Things to Consider When Upgrading From Epicor 905 to E10

People, Infrastructure, and Scope in an Epicor 905 Migration

A customer on the front end of an upgrade from Epicor 905 to E10 asked me for advice on ERP upgrade planning. I’ve long reflected on some of the keys to a successful Epicor 905 upgrade to E10—the lessons learned by decades of experience, and collected across countless end-of-project reviews. In light of wins and losses of the past, I’ve put together some thoughts on successfully upgrading an ERP system.

Working with consultants often helps in transitioning from a legacy ERP and gaining traction with the new version. This is especially the case if your business intends to leverage the upgrade as an opportunity to perform process changes, implement additional modules, or take advantage of new functionality. All of these things involve risk, largely due to the complexity of data amassed in the process. But if you consider your people, your infrastructure, and your scope, then an upgrade will be the best decision you can make for your future.

Cloud Consulting

Your People & Your Partners

Upgrading your ERP system is all about the people.

  • The people your upgrade will support
  • The people who will help make your application meet your goals

The Philosophy Behind Your People

Methodology: You want to work with folks who have a process for taking your company through the steps, so ’tis not a hodgepodge of random activity.

 

Expertise: I’d recommend you work with a consultancy rather than an independent “jack of all trades” — generalists are good for what they do, but I find the overall solution is superior when delivered by a coordinated team of folks. Look for specialization: Operations, Finance, Tools, Installation, etc.

 

Knowledge: This is where you want some good generalist know-how accessible to you when needed. For example, if you’re upgrading Epicor from 905 to E10, you’ll want someone around who has knowledge about 905 and expertise about upgrading to E10. This is especially helpful for tools considerations and code conversion, but not really important otherwise. The data from 905 to 10 is generally the same, and the functionality is also quite similar. If you have ABL code that you need to convert, you’ll want to partner with a team that has these skills.

 

Experience: This is key. In an Epicor upgrade, for example, you need folks who are strong in E10 and can recommend how the system will best run in 10, so that your transition is smooth and effective.

The Technical Nature of an ERP Upgrade

These considerations apply to any ERP, but I’m going to walk you through this with my Epicor consulting experience coloring the waters. In general, the move from Epicor 905 to 10 is technical in nature, with the change of the database and business logic layers from Progress to .net & SQL Server. Here’s a quick summary of some of the major changes and their implications:

 

Core Modules: These are very similar from 905 to 10 with some new sub-modules and lots of new bells and whistles. You’ll find many opportunities for changes in configuration, and some of these can create unexpected behaviors, so test carefully.

 

Updatable BAQs & Dashboards: These generally come over uneventfully, with a few tweaks. If they contain ABL code, some rewrites are required.

 

Embedded Customizations: These also generally come over uneventfully, with a few tweaks.

 

BPMs: Anything with Progress 4GL ABL code will need to be rewritten.

 

Configurators: Similar to BPMs, anything with Progress 4GL ABL code will need to be rewritten.

 

SSRS / Crystal Reports: 905 primarily uses Crystal Reports. In 10, these have all been converted to SSRS. If you have a lot of custom Crystal Reports, you’ll want to consider whether to rebuild these in 10 or deploy Crystal in the E10 environment.

At all levels, you have to assess the ERP system and the technology that supports it. When you’re upgrading a legacy ERP, should you also upgrade your servers? Will your system require new data management solutions like cloud-based disaster and recovery services? Are you facing new cybersecurity and compliance decisions?

 

Technical Considerations

Upgrading an ERP system demands skillful handling of data. This includes both the mind and soul of the ERP: the strength and spirit of the application. With on-premise, hosted, and SaaS solutions now available as ERP infrastructure options, your upgrade should include technology assessments both in and out of the software.

Upgrade vs. Reimplementation

Think about whether you want your ERP upgrade to be a straight, utility-driven upgrade from the legacy to the current version or a reimplementation. We’ve worked with customers who have gone either way.  We’ve found that reimplementation efforts tend to take longer and cost more, but leave you with a much cleaner data foundation.

A Data-Driven Epicor 905 Upgrade

If you’re trying to pull off some configuration/business process changes as part of the upgrade, this is easier to do as part of a reimplementation. If running Epicor and you’re looking to do the straight, utility-driven upgrade, I would recommend partnering with Epicor specifically to do the database conversion/upgrade. They have proprietary tool (“Cirrus”) that performs this upgrade, and it’s really the best way to do this. In the past, with early versions of 10, the upgrade toolset was part of the Admin Console, and partners like us performed the upgrade. Prior to the upgrade, we also had to request data scrubbing programs to run in 905 prior to the actual upgrade. These helped prepare the data for the 905 > 10 conversion.

Over the course of the last few years, Epicor developed the Cirrus toolset that performs the database uplift. This incorporates all that scrubbing and referential integrity stuff to successfully migrate the DB. These capabilities are not built into the admin console upgrade capabilities, so my understanding is that a better-quality uplift is achieved by working though Cirrus. As a customer, I would be working through Epicor to get the DB upgrading it, and not relying on the admin console. In reviewing the feedback from the Epicor user community, I think that the general consensus would be to leverage Cirrus when possible.

The Project Scope: Budgets & Ongoing Planning

Begin with your history. How to handle your historical data is unique to your project, and you might want to bring in a consultant to help you make decisions around the complexities. There are a number of additional budgetary/planning considerations that should be made at the onset of an upgrade project. Here are several that we normally work though with our customers:

  • Project Management: Do you have an on-site PM who will handle more of the PM duties, or do you want the partner to assume those?
  • Server Install/Configuration/Tuning: Who do you have for technical staff to assist with server-side activities, or do you want the partner to assume those?
  • ABL Code Conversion: Who do you have for development staff that can assist with code conversion, or do you want the partner to assume those?
  • Cirrus Upgrade: Are we working through Epicor to do the Cirrus upgrade? If doing a Cirrus upgrade, you should plan for that cost.
  • Delta Education: Do you want to self-educate or have your partner provide ERP training and support?
  • On-site Consultation: Do you want to have consultants on-site to assist, or do you want to have the partner working remotely and on-site on an as-needed basis?
  • Milestone Prep: Do you have resources that can perform the prep activities, or do you want the partner to assist?
  • Milestone Verification Events: Do you want to conduct CRP and UAT events on your own?
  • Gap Closure: Do you want assistance with gap closure, or do you want to spearhead this?
  • Customization/Tools: Do you have an internal resource to perform any new tools work (customizations, BPMs, reports, etc) that would be part up the upgrade project?
  • Data Conversion/DMT Assistance: Do you have a data-savvy resource who can own DMT & data questions and query the data out of the existing system, manipulate it to load into Epicor, and run the DMT tool to load?
  • On-site Support at Cutover: Do you want on-site support at cutover?
  • First Month-End: Do you need on-site finance support for the first month-end after cutting over, or do you have strong Epicor-savvy internal financial resources?

Upgrading an ERP system can be challenging. It’s a highly rewarding endeavor, and the outcome justifies the move. Good luck on your journey, and reach out to our experts with any questions you have along the way! 

 

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What Are My ERP Private Cloud Options

What Are My ERP Private Cloud Options

Not All Clouds are Created Equal: Reviewing Your ERP Private Cloud Options

 

It’s no secret that cloud computing has been increasingly finding its way into businesses by providing reliable solutions to increasingly challenging problems.  But for ERP customers with complex environment maps, an unmitigated move to the cloud might feel risky.  For this reason, some customers look for middle options between full cloud deployments and on-premise installations.  Private cloud hosting is one such midpoint, and it’s not uncommon for customers to approach the opportunities of cloud computing in search of a private solution.  But will this option leverage the obvious benefits of the cloud, while effectively providing the necessary support for your complex ERP ecosystem?

 

Your ERP installation is rarely an isolated entity—it is part of an integrated ecosystem of applications and processes, with various third parties, bolt-ons, and in-house applications interacting with the core ERP system.  As such, an ERP system is not always easily extracted from its ecosystem, as such an extraction is something akin to major surgery.  If you’re looking at handling this complexity with private cloud ERP deployment options, there are basically two management directions you can take.  You can build a private cloud using AWS, Azure, or Google, or you can work with an already established team of experts in private cloud hosting.  Let’s explore these options in greater detail.

 

Private Cloud in AWS/Azure/Google

 

The big players in cloud computing entered the application hosting game a while ago – Amazon, Azure, and now Google.  The option here would be to build out your virtual machine architecture within one of these clouds, and install your applications within this architecture, while working in turn to integrate your company-specific application ecosystem with the new ERP infrastructure.

 

While this eliminates the hardware investment of an on-premise install, you are still responsible for all the administration activities, at the server, application, and database levels.  And if your Epicor Admin should win the lottery, you are left scrambling for options.  If you lack the internal resources and need to bring in assistance in the administration of the application, you are now adding another party to work within this ecosystem.  Moreover, to your monolithic cloud provider, you are still just a number, and the service levels you can expect to receive will indicate as much.  Will the hosting company be responsive and listen to your apps and your business needs?  Is there a human voice to reach out to when issues occur?

 

Private Cloud Through the Estes Group’s ECHO Managed Hosting

 

EstesGroup’s EstesCloud Hosting, or ECHO for short, is our hosting platform. For one monthly price, we include all the functionality and support you need to keep your hosted applications running properly for your business.  While providing the access level that companies look for in private cloud solutions, we also provide the support and expertise that a big box store cloud partner can’t provide.  One phone call puts you in touch with our support team.  Well-versed in Microsoft’s full stack, we cover your servers with 24x7x365 EstesCloud Monitoring.  We cover the backups and disaster recovery, and we protect your users with EstesCloud identity management under the security of EstesCloud-managed Firewalls.

 

We have experience in moving many customers to a private cloud environment, while working with them to integrate their hosted ERP platform with their family of related applications.  With this experience comes the knowledge in working with protocols, networks, VPNs, and database connections, and we leverage this knowledge when engaging a customer.

 

In summary, some of the benefits of the EstesGroup’s ECHO Private Cloud Hosting solution include:

  • Known monthly expense, with no large capital expenses
  • Growth with your business supported by continual and customized service
  • Proven backup and disaster recovery playbooks
  • Easy, secure access from anywhere you wish
  • No Server Maintenance
  • No need to upgrade or repair hardware

 

When it comes to deploying your ERP architecture, there are clearly a number of different options, and the implications of the decisions made will have a lasting effect on your company’s future.  Are you considering spinning up your own private cloud to host your ERP application?  Drop us a line first, and let us help you explore your options.

Interested in learning more about Managed Hosting for Epicor ERP or Prophet 21 ERP?

 

Visit our Managed Epicor ERP Hosting page

Visit our Managed Prophet 21 ERP Hosting page

Epicor MRP Keeps You On-Time and Customers Happy

Epicor MRP Keeps You On-Time and Customers Happy

ERP!  ERP!  How do I love thee?  Let me Count the Ways: A Robust Materials Resource Planning ( MRP ) Engine

 

 

One of my favorite movies growing up was The Wizard of Oz.  One of my favorite scenes was when the “Wizard” was exposed as the “man behind the curtain,” pulling levers and revealing the secrets of the kingdom.  In the business world, this phrase has morphed into meaning a person who elusively controls the intricacies of a large enterprise—and no one really knows the who, what, when, or how of the magic behind the success.  MRP (Materials Resource Planning) is like this “man behind the curtain.”  Incredibly powerful, MRP manages the forces of supply and demand, keeping everything under control.

 

 

There are basically three questions that a manufacturer has, and MRP answers:

  • What does the customer want?
  • How many do they want?
  • When do they want it?

 

While those three questions seem relatively simple in nature, executing them in an efficient and profitable manner can become an extremely daunting, or even impossible task if you don’t have the correct tools.  Fortunately, the Epicor MRP Engine is a highly sophisticated but user-friendly process that can help companies increase on-time performance, lower inventory and improve efficiency.  MRP takes all three of these questions and looks at them holistically, to manage all variables that can occur on a shop floor.

 

What product does the customer want?

 

To answer this, MRP first looks to see if the part is purchased or manufactured.  At the core of the system is the type-attribute of the part.  Epicor defines a part in three ways: purchased, manufactured or sales kit.  Purchased Parts can have a defined lead-time and are used in determining when product can be available if stock is not available.  Manufactured Parts are built-up with routings and bills of materials.  MRP will take into account the time it takes for each operation, dependent on the quantity and material availability, to determine when the product will be available to ship, based on capacity on the shop floor.  Sales kits can be a combination of purchased and manufactured Parts and will use either or both types of logic to determine availability.

 

What quantity does the customer need?

 

Based on demand from forecasts or actual Sales Orders, the system looks at the current inventory level.  If there is insufficient inventory, it will suggest to the Purchasing Department to buy some if it’s purchased or will suggest to the Planning Department to create a job to make some, if it’s manufactured.

 

What is the customer’s timeline?

 

This is where the Epicor MRP logic will take the first two questions and analyze two things: If we don’t have it in stock, can we buy it in time to deliver it, or do we have enough material and resources available to build how many they want?  And it does this by taking into account not just one particular Sales Order, but all of the Sales Orders, and all of the inventory stocking levels and Job demands within a plant.  Obviously, this is a very tall order, and in a dynamic manufacturing environment, things are often changing on a daily, if not hourly, basis.  Because the MRP process can be such an intensive hardware resource demand, Epicor can be configured to run on a schedule (often times at night), either by looking at net change (to only work on those things that have changed since MRP was last run) or by being regenerative (to recalculate all demand).

 

Epicor also has the ability to run MRP for a specific part.  Have a customer that needs a part ASAP?  Now instead of having to wait for MRP to run, management has the ability to see the potential status of a job in a matter of minutes, and not hours, as MRP only has a single part to analyze.  The MRP process can also be limited to a plant, product family, or commodity class—reducing the time and resources required to generate the needed supply records.   Epicor MRP also supports multi-level pegging, which gives users the ability to trace the supply to each discrete source of demand.  This process also drives the projected Sales Order shortages and is an incredibly powerful tool to manage customer satisfaction.

The Epicor ERP system, in conjunction with its versatile and powerful MRP process, allows your organization to “see behind the curtain” at an organizational level, revealing what the current demands for your products are and if you have the necessary supply to meet demand in a timely and profitable fashion.

 

There are lots of things to love about Epicor’s E10 ERP application.

 

Want to know a few more?  Read our “ERP! How do I love thee?” series and give us a call with any questions you may have. 

Do you want to learn more about Epicor ERP and MRP? Download the Manufacturer’s information packet.

Manufacturers are in Love with Epicor ERP

Manufacturers are in Love with Epicor ERP

ERP!  ERP!  How do I love thee?  Let me count the ways!

 

I’ve often remarked that the best way to get a company to fall in love with their legacy ERP (Enterprise Resource Planning) system is to implement a new one.  When I was a customer, we moved from one of Baan’s flagship products to Epicor’s Vantage 803.  ERP implementation is an exercise in nostalgia…  With uh or ah or awe, does anyone out there remember Baan, or Vantage, for that matter?

 

I do remember the end user community at cutover:  “Well, back in the Baan days we could do this, and we could that, and oh, I miss the Baan days…”— Folks who had never had a good thing to say about their enterprise system were suddenly swooning over it, now that it was on the outs.

 

Having heard nothing but complaints about our legacy ERP up until cutover, I didn’t know what to tell them.  At a loss for words, I found myself quoting Lord Alfred Tennyson: “’Tis better to have loved and lost than never to have loved at all.”

 

I soon discovered that most end users in your average manufacturing company are not especially fond of nineteenth century British Romanticism, especially at cutover weekend.

 

Most companies don’t exactly love their ERP systems, even in a friendlies sort of way.  I knew one fellow who had the source code of his ERP heavily modified to suit his exact needs.  Of course, he loved his ERP—every time he used it, he was looking in a mirror.

 

For the rest of us, ERP is more like finding a roommate rather than a soulmate.

 

Even still, there are a lot of things about Epicor ERP’s Epicor 10 platform that can spur admiration—even affection.  Last year, I wrote an article about Epicor’s E10 platform, looking to answer the question: “what’s it good for anyway?” It turns out that E10 is good for a lot of things:

 

In this series, we will further expound on the core capabilities mentioned above, and work to explain how these capabilities distinguish Epicor E10 from its competitors.

 

What’s it good for anyway?

 

Companies in the midst of a software selection cycle are looking for things to love about a given system—things that will differentiate an ERP system from its competitors and that will ultimately help raise the business to greater levels of performance.  With the New Year moving right along and Valentine’s Day on the horizon, are you ready to love your ERP in 2020 style?   Whether you’re looking for some new Epicor E10 roomies or looking for someone to draw hearts around a new flame of a system, the EstesGroup team is ready to help you love the ERP you’re with.

Interested in learning more about Epicor ERP 10 customizations and how good consultants can help manufacturing companies? Give us a call.

To begin looking closely at Epicor’s full ERP power, download one of our white papers.