Agile QMS: how QMS software can grow with your organisation

What is needed for agile QMS?

Very often, eQMS software is fixed configured and as such, is to be used exactly as it is designed. This requires a specific way of operating, which you cannot adapt to the culture of your company. Such an approach can work unless you find yourself in a larger environment. In that case, the requirements of a Quality Management System become more decentralised, more employees are involved with Training Management, and the follow-up processes become more complex. That is when the use of a smaller eQMS tool runs into its limitations.

Larger platforms are configurable and grow perfectly with your organisation. However, you often have to call on the consultants of that software for adjustments to the system. This makes reconfiguration of processes time-consuming and expensive.

Which approach works best for agile QMS?

The best of both worlds is a platform that is flexible and easy to configure in a visual way, without coding. In this way, business employees (in Quality or IT) can modify a great many processes themselves without a single code.

In practice, we see that companies usually prefer a mixed approach. During the start-up of the first processes, our consultants are strongly involved and help to get the train on the rails. Once this is running smoothly, the customer gets to work and only contacts us back when there is a lack of time or when things become too complex.

"You should be able to adjust 90% of your QMS yourself, without coding."

Most QMS system platforms are designed exclusively for Quality Management, while a generic workflow platform is actually better. This type of software gives you the flexibility to work the way you are used to. This enables large organisations to use one single application to automate various business processes, some of them quality-related, some not. Documentation Management for the marketing department, processes for approval of investment requests, customer requests, material creation... are common processes.

"A pre-configured database can contain 80% to 90% of the processes an organisation needs."

A system that grows with your organisation

Start-ups or scale-ups also get "good value for money" from this kind of software. If you start your business with Quality Software that evolves with your company, you will have no need to replace it later on. It begins with the processes that are essential at that moment. As the organisation grows and the needs become more complex, you can only benefit from software that takes you all the way, especially within QMS and regulatory compliance, but also for processes outside of that scope. And the possibility of this being done without any extra cost or effort is a bonus.

"Go for a Digital Quality System that you just can't outgrow."

Especially if you work in the context of life sciences (medical devices, pharmaceuticals, etc.), you definitely do not wish to switch to other quality software in the long run. In order to be perfectly compliant and meet the requirements of ISO 13485, 21 CFR Part 11, and GAMP 5, your entire Quality System has to be integrated into the software. When migrating to a new platform, the conversion of the data has to be validated, in addition to the new software. This is nearly impossible because you have to prove that you have copied all the data without any loss. As an alternative, you can opt to print or export all the data, or to keep the old tool as an archive. This scenario is cumbersome and expensive because you continue to pay for the archived database in the old tool for several years.

The best software for QMS scales with your business and covers all requirements.

Flexibility for agile QMS is key

The need for flexibility within Quality Management is growing and many companies want to get rid of the rigid framework of a fixed software solution for QMS. However, working on programming a digital system yourself is not the ideal solution in terms of cost and lead time. (Read the blog 'The pitfalls of do-it-yourself') The truth, as so very often, lies in the middle.

By Peter De Brabandere, Founder of BizzMine