What is the main difference between a paper-based QMS and an electronic QMS?
Why would you bother going from one to the other?
Is it worth the effort and the resources?
All valid questions and multiple possible answers...
A paper-based QMS is the "traditional" way of documenting a Quality Management System. You have a specific set of approximately 20-30 procedures, a Quality Manual, and a bunch of forms. All of them written in Word and/or Excel.
The good news is: it can work. It has worked for many years. If you have someone that has the time to maintain it, chase signatures, makes sure everyone is well trained, is aware of changes and knows how to control everyone within the organization so that they do things the way they should be doing, you're good to go. No need to change.
However, you might face a few issues along the way. And what we see quite often is that people work "more or less" according to the procedures (or what they remember from them) and that everything is "put in order" just before the audit.
|Advantages paper-based QMS||Disadvantages paper-based QMS|
|Most people know how to work with Word/Excel||It's not obvious to work together on the content of certain documents|
|Most consultants/ RA/QA professionals are used to work in this way||It's not easy to have an overview and control over the links between different documents|
|It's easy to change things||It's hard to do proper version control|
|It's easy to print things||It takes time to approve documents that need to travel from desk to desk|
|Due to the longer review and approval process, small but important changes and improvements might be postponed. This means you might need to work with sub-optimal processes for an unnecessarily long time|
|It's not always obvious for people to know which is the latest approved version of a document|
|How to find back older, approved versions?|
|What happens if the binder with signed procedures gets lost??|
If you're looking to manage your QMS in a more efficient way, you might soon end up looking for another software solution.
What can an electronic QMS bring you?
What you hope an electronic QMS will bring you are:
- One central point of reference
- Easy and thorough change control
- Electronic signatures/approval
- Facilitate the way of working, not make things harder
- Facilitate gap analysis with standard or legislation requirements
So are there no disadvantages?
Well...it depends what you call a disadvantage.
- It does require some time, thinking and effort to transfer from one to the other, but that shouldn't scare you off. There are many approaches on how to handle the transfer from a paper-based to an electronic QMS. We've written a blog article before on when to switch from one to the other.
- Not only do you need to create your QMS in your new tool, you need to validate it as well. And re-validate when there are major changes. What is required for validating your QMS software and how to do that in an efficient way, have been the topic of previous posts as well.
- There is of course the change in mindset that is required. Saying goodbye to what we know well and being open to improvements is not always easy. But in the end, when people see the advantages of a lean and agile electronic QMS, they should be convinced.
So in summary, it is worth to spend time implementing an electronic QMS, provided that you choose a tool that fits your organization.
What if you have no QMS yet and you need to start from scratch?
Have a look at our series about starting a QMS from scratch
- 3 questions to ask yourself at the start
- Writing processes
- Reviewing processes
- A risk-based approach for processes
- Releasing processes and training people
- Creating records
- Organizing internal audits
With MatrixQMS, we have developed a tool that allows you to implement an electronic QMS, manage records, trainings, audits and track compliance.
If you want to have more information or a demo of our tool, don't hesitate to reach out!