Audit Manager, from Focus Informatica vs. Qualio

This is one of the most user-friendly QMS programs I have used because it does not require lengthy training to navigate the system. We are able to bring on a new employee and have them start their own initial onboard training in Qualio with only a simple introductory message that shares a few key instructions. The available training in Qualio Help has proved very effective when needed. An individual can pick whatever training is appropriate at that moment and there will be instructions on demand on any topic related to Qualio operations. Qualio is relatively new software and is maturing with a responsive staff that releases new updates on a monthly, weekly, or even daily basis. It has grown incapability in the two years I have used it and it continues to evolve through customer inputs and looking at other state-of-the-art products. The staff listen and respond quickly compared to my past experiences with other QMS software. There is an opportunity for them to provide more and better features, but the gap is closing and the Qualio engineers have been very collaborative to work with, providing us opportunities to participate in their directions for growth.

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• Readily available policy documents to access any at any time which we wanted to access.
• Quickly identify, understand and compare the older and newer version difference of the SOPs and to understand the changes which have made.
• all the SOPs DOPs at the same place with secured access.
• Particularly the upgraded version of Qualio is so classic and the dashboard and menus are easily able to understand to any new user as well.

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• I would appreciate if similar documents are grouped together. For instance if engineering documents are put in one category and management document in a different category
• Qualio has links to external documents but it would be helpful if it linked the user to sections within the document also
• I would prefer that users be able to purchase licences directly without contacting a representative

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as i already mentioned earlier.... Qualio definitely makes things run smoother, especially with keeping compliance in check and reducing errors. The setup took a bit to get everyone on board, and yeah, the costs can stack up over time. But overall, it’s been a solid tool that’s saved us time and stress, so it’s definitely worth it.

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I think the system is usable, but only to a certain extent. If the organization using Qualio did not outright need audit trails and functionality around metadata compliance, then it would be an okay system to use. However, there are systems that are approximately the same cost, but are fully compliant. It depends on your organizations needs

Two great things Qualio has for customer support. 1. They are available online and on the phone, if needed, 24/7 with very friendly and knowledgeable people. Usually, the wait is no more than 10 or 15 min, and while you wait, you can search their online help library. I used to call first, but now I've found that their online help library usually has he answers already and the instructions are clear. Usually, I learn more than I needed. So I now go there first and only call if I don't find anything in the online help library.

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We selected Qualio over Greenlight Guru because of the flexibility offered in adapting the system to support software as a medical device (SaMD) processes. Greenlight Guru was more expensive and very focused on hardware medical devices which did not fit our needs.

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• The number of emails received.. end up just deleting as it is spamming my inbox.
• Benefitting from E-sign approvals.
• Keeping track of our documents in a efficient and better way.
• Amazing to use a cloud based system where everything is not on paper.

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A de minimis incentive was given to thank the reviewer for their time. The incentive was not used to bias or drive a particular response, nor was the incentive contingent on a positive endorsement. More Info