Advantages and disadvantages of e-QMS in medical device companies

The use of online solutions for the compliance with voluntary standards and legal regulations are becoming more popular among any size of companies of every sector worldwide. In this article we will analyze why the use of these software tools can help medical device companies with the compliance with quality standards such as ISO 13485 or ISO 9001 in an effective and successful way.

What is an e-QMS?

Until few years ago, companies used to complete a pile of documents that were saved in the quality representative’s computer and with luck, these documents were appropriately coded, and the latest version was uploaded to the correct folder. Therefore, control of documents in the organizations became more a headache than something that could actually bring some benefits to the implementation and maintaining of the Quality Management System (QMS).

The release of software tools, such as e-QMS (electronic Quality Management System), has undoubtedly marked a before and after in the implementation and maintaining of international standards, and especially in the part of document and record control. Using an e-QMS companies ensure that all changes are tracked and latest versions are uploaded to the system, but even more, depending on the solution used, implementation processes will be automatized to a greater or lesser extent, going from the creation of the quality manual, establishing the quality policy and objectives, defining all stages of the product realization, and all the remaining processes needed to complete the implementation of the management system.

Advantages and drawbacks when using an e-QMS

Surely the advantages when using an online solution to comply with a QMS system are far more numerous than the drawbacks, and it is very simple to understand the reasons which I explain below.

1. Effective control of documents and records

The first advantage, as I previously mentioned, is ensuring that all documentation is controlled, which is the basis of every management system and the first step necessary to efficiently implement a quality standard. You will know where your procedures and records are, what is the current version, who is responsible for which document, and you will make sure that your documents are effectively protected, among others. I would affirm that just for this reason it is worth to rely on an e-QMS, but let’s continue with other relevant advantages that may positively impact the quality of your medical devices.

2. Automatization of the implementation process

The next advantage is the automatization of the implementation work. You will not have to figure out where to start the implementation or how to handle difficult processes such as recording non-conformities and conducting corrective actions, the e-QMS will guide you throughout all the implementation steps and you will just need to enter your data into the system and documents will be automatically generated.

3. Dealing with complex terms of the standard

Many companies struggle when trying to understand the requirements and different terms used in the standards, and this definitely affects the speed of the implementation project. An e-QMS translates these complex terms and technicalities used in the standard into comprehensible language and even beginners should be able to complete every template in order to comply with the requirements of the quality standard.

4. Reduction in the implementation costs

Costs will be significantly reduced since you will not need to hire external consultants that do all the work for you and surely you will not waste time dealing with the different and complex requirements of the standard. The e-QMS will provide you with all necessary templates to fulfill the requirements of the quality standard and will ease the implementation project for a successful certification. Furthermore, an on-line solution will later help you during the maintenance of the system, even more important than the implementation process.

5. Protection of documents

Nowadays data protection is one of the biggest issues that medical device businesses are facing towards their patients and other interested parties, such as employees or suppliers, and of course regulators. Using an e-QMS for the document management will ensure your data is protected, and your information is backed-up regularly. You will have the tranquility that just the correct people assigned for every process and document will be able to access, edit and review the QMS documentation using a single ID and password.

6. Monitoring of the QMS project

Another benefit of using an e-QMS is that tracking all the processes and the progress of the implementation will be much easier. Usually, these types of online tools have incorporated a dashboard that will help you to monitor planned activities and deadlines for every process. You will be able to rapidly spot if any internal issue is happening in the implementation of the management system, such as the lack of resources or engagement, and effectively overcome any problem in less time than when an e-QMS is not used.

7. Easier auditing process

Using an e-QMS during the audits will surely help you to face this process with more confidence. You will easily allocate every document, from policies, procedures, work instructions, and others, in order to show compliance with every requirement of the standard. Also, this on-line tool will be the evidence for the fulfilment of the requirement of the control of documents and records.

Disadvantages when using an e-QMS

As I have already evidenced, there is a large list of benefits when using an e-QMS, however, we also need to take in account the disadvantages, that can play against our management system implementation and finally, your medical device business and patients.

1. Choosing the right e-QMS

Companies can have some difficulties when selecting the right on-line solution for their companies. The world is full of inefficient on-line tools, and this can be risky for our business, and of course a waste of money, so make sure you can trust the provider, looking for previous customer opinions and other references, but also ensure that the provider of the e-QMS can offer a warranty of the product and service provided, for instance, signing an agreement.  

2. Complex and inaccurate documentation included in e-QMS

When a business starts the implementation of a QMS is not frequently familiarized with the documentation that should be included in the system, and which documents and records are mandatory and which ones are just voluntary, This can be an important issue, so make sure when purchasing an on-line tool that it contains all the necessary documents to comply with the standard, the sequence seems to make sense, and the documents are easy to fill out, for instance, containing information about how to complete them.

3. e-QMS Investment

This can be seen as a drawback at first since your company needs to invest some money at the beginning of the implementation. Nevertheless, this will definitely be worth taking in consideration the previous written section of advantages and how much benefits your company will obtain in return.

4. User-non-friendly

Sometimes some solutions sold as user-friendly are actually the opposite, very difficult to follow and understand, from how to manage the different widgets, the board, even simple things such as assigning responsibilities can be a nightmare for the company, and at the end, a waste of time and money. So, make sure you receive a demo before purchasing the e-QMS to ensure you will be able to easily navigate through the tool and have access to technical support whenever a problem arises in the implementation or maintaining of the system.

Is an e-QMS the best option for my company?

Consider the advantages that an e-QMS can bring to your medical device organization, taking in account the size of your business and complexity of your products and services but do not forget about the drawbacks that may drive your company to fail the QMS certification. If you decide to purchase an on-line solution, ensure that is it a reliable company that will make your business not only to comply with the requirements of the standard but to grow and be more competitive in the market.