Case – Startup company

Today a startup is recommended to build up directly its eQMS. Typically, startups are first focusing on the product development and clinical studies. Production and complaints come only in a later stage. With time the number of users, processes and complexity grows significantly. It is thus more difficult to foresee the needs in later stages. However, the following checklist might help to find the right eQMS.

eQMS checklist – content

– dashboard
– SOPs / records
– records (ERP, suppliers, DHRs)
– document change
– product development
– infrastructure
– suppliers
– production
– training
– audits
– complaints
– improvements
– KPI’s
– Others

Case – existing (e)QMS

The transfer from an existing QMS to a new eQMS also has its challenges. In this case the complexity of the processes, the typical users and other circumstances are already well known. The step from one world to another is emotionally challenging, long-lasting and needs strong leadership. Clearly, key users must be involved in the evaluation of an eQMS and the requirements and the budget should be agreed with the management at the beginning.If one starts to compose a short-list of possible products, one realizes, that this selection process is time consuming and complex.

By grouping the features of different eQMS systems, it becomes quickly clear, that not only the visualisation and the content vary but also other evaluation criteria such as listed below may limit the selection. If the shortlist becomes smaller and smaller, it is most useful to visit already existing users in other companies or to have access to a dummy environment with the entire user evaluation group.

more evaluation criteria

– customizable, modular software
– preconfigured SOPs available
– hardware requirement
– software requirement (Microsoft)
– software validation
– license models
– others

The implementation or the change from one QMS to another eQMS must be well planned and structured. It needs heavy endurance and support from the management and all users over the entire change period!

In the end, the introduction of a new eQMS should include and motivate all users to make the processes more effective and reliable. Even if an eQMS is powerful, it is thus important to focus on priorities and to keep processes as slim as possible.

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Part 3 – internal audit

Part 4 – management review

Written by Dr. Thomas Hug, October 2023