How to Support ERP Implementations in Regulated Environments

When discussing enterprise resource planning (ERP), different resources might get you different answers on what it really is. However, you will definitely come across a running theme of an integrated management system for an organization’s major business processes. Also, it most definitely includes a technological approach, usually with the help of specialized software.

To take the complexity even further, implementing ERP systems in regulated environments places additional restrictions to your systems. This poses the challenges of planning, implementing, and supporting your ERP system in environments such as the manufacture of medical equipment and pharmaceutical products. In fact, the United States Food and Drug Administration has laid out a set of regulations to maintain manufacturing standards and protect consumers.

Here are some of the steps from IFS consulting services experts at Corning Data you can take to make sure you keep your ERP implementations supported, even in regulated environments.

Including all end-users in the decision-making process

A common oversight in the implementation of ERP systems is the shifting focus towards leadership executives, gearing the program towards gaining approval from the management instead of catering towards the needs of the actual end users who will be using the system.

Engaging all stakeholders from the planning to the implementation is a way to make sure that all restrictions and guidelines are followed. This goes beyond the administrative and information technology departments. It’s important to gain insights from finance, manufacturing, and supply chain sections of the organization. More importantly, in a regulated environment, it is imperative to have an understanding of the guidelines applicable to your products and services

Discuss it with your Service Provider

Legacy ERPs refer to older enterprise systems no longer enhanced, mostly those made from the 80s and 90s. To make sure that your system keeps up, both with the needs of its end-users and the restrictions included in being in a regulated environment, a shift to cloud-based ERP software systems might be the next necessary step. While most legacy ERPs have been bought and reconfigured for cloud-compatibility, it’s better to make sure if the same capability is available for you if you already have an existing system.

For those planning to implement from scratch, try out ERP systems offered as Software as a Service (SaaS). It means that the entire system is hosted over the cloud, on the service provider’s systems, and you access the information and services you need over the Internet. While it uses the Internet as the medium, their servers are extremely secure and the services you can avail are flexible.

Also, there are service providers who have their own team of consultants intended to work closely with your end-users to identify measures and capabilities you need to make sure that you roll out a fully functional ERP system compliant with existing regulations for your particular industry.

Prepare a Sufficient Time Frame and Budget for your ERP Implementation

One of the trickier parts of implementing and maintaining an ERP system from an administrative point of view has something to do with the costing. Sure, getting a SaaS ERP might start with considerably high upfront cost compared to Legacy ERPs or native cloud-based ERPs. In SaaS arrangement, you partly pay for the infrastructure you for as long as you are subscribed to the service, instead of having you invest in your own on-site or cloud-based infrastructure. It is important to be familiar with the costs that will come with the services you intend to use.

Also, costs for the ERP implementation in regulated environments does not end with your periodic subscription for the services. You also have to invest in the training of your personnel to make sure that someone is on top of the upkeep, even after the system has been implemented. You will need skill and competency to make sure that the system works as planned. Analysts have estimated that around 75% of ERP projects end up in failure.

Also, before proceeding to take the first step, make sure to allot sufficient time for all parts of the project, from planning to implementation to maintenance. After defining the estimated timeline for the project, expect extensions and make sure to plan accordingly.

Define Security and Access Restrictions

While visibility and accessibility is important for ERP implementations, it is even more important to maintain that the right people gain access to the right areas of the system. A security breach can just as easily bring down the organization as any other disaster scenarios. In finding the right ERP system, make sure that you at least have the following capabilities:

1. Customized security measures. Every organization has varying security requirements, more so for those working in regulated environments. The system security has to be tailored specifically for your company.
2. Duty segregation. Both data and financial transactions should have an authorization process enabled by an individual not directly involved in the transaction.
3. Data encryption. This ensures that only official stations and portals of the system can access and display your company’s data, proprietary or otherwise.
4. Audit trailing. Every transaction can be viewed for investigative or auditing purposes. Moreover, every change log regarding your files and data must be capable of tracing who made these changes and where and when these were made.

Lastly, Electronic signatures and multi-level checking is a necessity. The Code of Federal Regulations issued by the USFDA covers the specifics for limiting system access for authorized personnel, the use of operational, authority, and device checking. Failure to comply with this CFR might result in fines or sanctions.

Implementing an ERP system is already difficult in itself, doing this in a regulated environment puts a whole new level of challenge for planners, IT consulting services, and all stakeholders involved. Still, with careful planning and execution guided by published guidelines increases your risk of a successful implementation.