The first time I heard someone say they were considering using their ERP platform as their quality management system (QMS), I was pretty sure I had misheard them. However, by the third time I heard it, I realized my hearing was fine. I think it’s important to talk about this because leveraging an ERP platform for managing quality processes doesn’t make much sense. Of course, ERP vendors will have a different opinion. However, I am confident I am right, and I’ll explain why.
Software is Optimized for Specific Data & Processes
Let’s start with an analogy. Sometimes when I am trying to rush through a household repair and need a hammer, but one is not within reach, I do bang away with the blunt end of a screwdriver or the bottom of a drill. But it never ends well, and sometimes there is blood involved. That’s because screwdrivers and drills aren’t meant for banging on nails. A hammer is designed for that type of object – a nail – and that type of task.
My position on software platforms and categories is based on the same concept: broad classes of computer applications are optimized for specific data types and certain types of tasks. In fact – and please remember, I have been in the software industry for a very long time – I do remember a product, Lotus Symphony, which at its core was a spreadsheet but purported to be a usable word processor as well. Unfortunately, that did not go well because the type of information and the type of tasks were too different, and one application could not span both domains.
So the basic idea is that broad categories of software systems or platforms are defined by the fact that they are optimized for a particular class of information and a specific type of task. This is a fundamental organizing principle for building a portfolio of software solutions at the enterprise level.
ERP systems, for example, are organized around the concept of recording and connecting transactions. That is what they are built for – transactions and tracking them – and what they are good at. CRM systems are designed to track the status of activities and to track and support processes, like sales pipelines. That is what they were designed for.
Taking Advantage of Existing Software Makes Sense, But…
I should say that I am all for expanding platforms you already have in-house to address new areas and use cases if they line up with the type of information and the type of task that the platform is designed for. But I am against it when the reason for using the wrong platform is driven primarily by the argument that “well, we already have that platform.”
That often happens when organizations consider expanding their ERP system to manage the quality function. They have the platform in-house, and the vendor says they have a module for a particular function, and it seems like a good deal to leverage the platform already in place. But to me, it is a mismatch, which, while expedient, fundamentally does not make sense.
Let’s think about what a quality management system does. A typical QMS manages and tracks a process in action while that process is executing. For example, the initial issue or deviation launches an investigation and, depending on the results of the investigation, may lead to a corrective action (CAPA). And depending on the type of CAPA, a new SOP may be required.
All the while, the QMS notes what happened and guides the process forward on a dynamic basis. A QMS system is fundamentally designed to guide, track and record complex activities. And that is not what an ERP is designed for (it’s designed to record transactions). When you look at the quality offerings from ERP vendors, that is what they do, record activities that have occurred, not guide users through a process.
A QMS for pharmaceutical companies separates the requirements even further from what an ERP does. Because being a pharma system brings in compliance requirements for tracking documents, maintaining an audit trail, and being a fully validated system. All the things to address 21 CFR Part 11 in the United States and similar requirements for virtually every pharma regulatory authority globally.
I am not saying you can’t use an ERP system as your QMS. I am saying you probably shouldn’t.
However, an ERP can be used in conjunction with a QMS at the start or end of a quality workflow. For example, ERP master data, such as batch numbers, material or product codes, and supplier information, can be input into the QMS. You can also update the ERP system with the status of manufactured products or batches, including if it was released, rejected, put on hold, etc.
QMS Software Helps You Focus on Quality Processes
If your objective is to invest in a system designed around the requirement to track, guide and record the process of capturing quality issues, managing them to resolution, and doing so in a manner consistent with regulatory requirements, a software platform designed will deliver the best value. It will be easier to set up, easier to use, enjoy faster adoption, and meet the requirements more effectively than an ERP system that has been extended beyond its natural capabilities.
Based on a few decades of implementing QMS applications in pharma companies, this is my opinion, and I’m sticking with it. Do you agree? Let’s have a discussion.