How to Choose Quality Management Software?
Allan Murphy Bruun
Fully Validated eQMS for Life Sciences – Save Time and Stay Compliant
How can you recognize a good Electronic Quality Management System Software (eQMS) and what to look out for when shopping for one?
Before we dive into it, we need to address what a good eQMS is and what value can it bring to your business.
Electronic Quality Management System (eQMS) software is a digitalized version of a traditional paper-based QMS. The replacement of paper with digital records offers increased effectiveness, reliability, and transparency of processes. The software is sometimes also called an Enterprise Quality Management System which is just an older term for an?Electronic Quality Management System (eQMS).
The most important aspect of any eQMS is of course its specific fit to your business objectives. Each company needs a slightly different solution based on its size, industry, or internal processes. But I guess you already know all that. You already know which processes are inefficient and you know which requirements your Quality Management System needs to fulfill. So how can you find out which eQMS solution will support your QMS processes and make them more effective? Let’s find out.
Pre-Validated or Not?
First, it is important to consider whether you need a validated eQMS.?ISO 9001:2015?doesn't call for software validation. However, companies that need to comply with?21 CFR Part 11,?GxP/GAMP, or?ISO 13485:2016?will require to run a validated eQMS.
There are a few possibilities when it comes to the?validation of an eQMS.
You can do it yourself, with help from a vendor, or buy a pre-validated product. Pre-validation means that the system was tested before use. Unvalidated software can create an additional workload. You will need to manually test the workings of the software and possibly hire personnel that is qualified to do the testing.
Furthermore, if you make changes or adjustments to an eQMS after the initial testing you will have to go through that process again. Pre-validated software takes care of this for you and provides a much faster and hassle-free implementation.
Other than that, there are still a few things to keep in mind when shopping for a good eQMS.
The Implementation Process
The most important aspect of switching to a digitalized QMS is time. The time it takes to make an eQMS fully functional typically hinges on the quality of implementation.
The key elements of an eQMS implementation typically involve:
These parts of the implementation process go hand in hand with the features that your chosen eQMS provides.
Recommended Reading:?eQMS Implementation Process [Checklist]
Ready-to-Use Solution for Life Science
A Ready-to-use solution means that the software is ready to be used right after purchase or needs very little configuration. It typically involves a set of standardized processes and features that can create value from the get-go. This feature is important because some vendors provide an eQMS that needs more configuration.
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Pre-Made Templates
Templates are standardized forms of specific document types that can make the process of QMS set-up or QMS upgrade easier. One example could be if you are upgrading or updating your current QMS to ISO 13485:2016. In such cases, you can ask your eQMS vendor if they have ISO 13485:2016 QMS-templates readily available that make the process of upgrade and implementation simpler.
Automated migration process
If you have a lot of historic documentation it is a good idea to look for a company that offers automated migration. The process of automated migration transfers all of your documents and records into the eQMS software. It is also important that the company offers proper documentation that proofs and validates the data transfer.
How Long Does Training Take and How Is It Conducted?
When considering your final picks, it might be a good idea to ask about the employee training specifics. Good training can make or break an efficient eQMS and you should make sure that the training will be effective and sufficient. It is also a good idea to ask your vendor if training needs to be paid for separately or if it’s included.
Training and Support
Proper training should not be a one-time event. It should include several occasions where your staff receives the information and tests them out in practice with guidance. Overview training followed by hands-on training with immediate feedback is typically the fastest way to familiarize employees with the eQMS software. The final aspect of the training is that it should include training material that allows for easy training of newcomers. Ask about specific outcomes of the employee training and their expected competence level.
The second aspect is user support. Your eQMS is implemented and fully functional but something goes wrong, or you need to perform a specific procedure within the software but you don’t remember how. It might be very helpful to have an eQMS provider that has your back in any situation and provides quick and reliable advice on any issue. Ask about specific support options when contacting eQMS providers.
Do you want to learn more?
This is a shortened version of the article. If you have enjoyed it so far you can find more content in the original blog post HERE.
In the original article you will find:
What’s the bottom line?
When choosing eQMS, it might be a good idea to opt for a pre-validated eQMS. Especially if compliance with ISO 13485, 21 CFR Part 11, and/or efficient workflows are your priorities.
It also makes sense to pay close attention to the training and support provided by the eQMS vendor. Good support and high-quality training can make all the difference in your day-to-day interactions with the system.