QT9 is a very solid and dense software that can be tailored to the needs of any business. User access and admin controls are very deep and easy to use. The module and workflows are plentiful, and while they can be intimidating to implement, once you dig in a really understand what the software features can do, the reward is high as the software is able to create and track so much.

The ability to creature user defined fields that could be tailored specifically to the record of document that was being created in the system was extremely useful when transitioning from established Quality processes from our previous paper-based QMS to this electronic software.

Implementation was a bit of a challenge. While we did have support from the developer and implementation team, the training seminars available were not nearly as helpful as simply diving into the sandbox environment and see what the system could actually do.

We have observed several benefits from moving to QT9. It has allowed us to move from a paper based/manual QMS system to an electronic system and reduce our paper consumption and record storage. QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process. QT9 made it possible for our organization to effectively maintain and continue operating our QMS system without interruption during the global pandemic when limits were placed on gathering size. All of our records are now in one location and it has reduced the time that the organization and Quality unit spend in locating records.

QT9 allowed us to replace our clunky paper based QMS and move completely to a streamlined, validated electronic platform. The ability to easily manage our document control, auditing, non-conformances, corrective actions, preventive actions, complaints, and calibrations in one location instead of having to spend time retrieving records from multiple locations. QT9 made it possible to maintain our organization's training needs during a global pandemic, when meeting face to face and in groups was restricted. QT9 made it possible to conduct remote training of our organization and evaluate effectiveness with a written test. It unknowingly prepared us to maintain all of our core Quality functions in the midst of a global pandemic without a mis-step. The report format (complaints, corrective/preventive actions, non-conformances, etc) look professional and they are able to quickly be downloaded and provided to either customers, suppliers, auditors, and internally. The consistency of the appearance of the screens in each module made training the organization to use very easy. It was easy to translate the learnings from one module to another. Implementation was similar as well. QT9 technical assistance in uploading of documents and gauges increased the speed in which were able to integrate it into our organization. The unlimited training was also critical especially for the calibration module as it took a bit longer for us to implement and understand how it functioned.

One feature that would benefit from improving is the ability to create both corrective action and non-conformance records from a customer complaint. Currently, the software only allows the creation of one or the other, but not both. However, all records between complaints, corrective actions, and non-conformances are linked through a daisy chain scenario, but it can be awkward when retrieving records during an audit. The calibration module was the most difficult for us to implement as it operated a differently than the other modules. However, QT9 technical support assisted and provided us with all of the training that we requested without delay and worked with us to ensure that we implemented the module correctly for our organization's needs.

To be honest we do not use all the modules within QT9 but the ones we do use allow us to get by and pass our QMS audits, but for the power user like myself that wants to extract detailed performance data you’ll have to extract the data and pull it into excel and manipulate it to get metrics you need. What you see is what you get, no customizing nothing. No overdue notifications or escalation process built in.

Ease of rolling out the product. Built in forms are helpful for a beginner. There are some features if you dig into the settings that allow you minor custom uses. The Calibration and Prevenative Maintenance Modules are promising and somewhat helpful. The document control module has worked well for us.

1. the biggest disappointment - No customability of modules and forms. Lots of tabs on the nonconforming product and corrective action forms and you cannot get rid of the tabs you do not need, You cannot even hide the tabs. Absolutely no customization to tailor to your organization. 2. No email reminders if you have overdue actions pending, you’ll have to look at the database daily. 3. No filtering of overdue items in perato analysis. You can filter: Open Items, Closed, Rejected, Submitted and deleted but nothing to tell you if an item is past due. No email notifications if an item goes past due. You can only disply the entire reports that are overdue. 4. Ad Hoc Reports are Lackluster for reporting performance data analysis (Perato Analysis, Bar Graphs, Line Graphs etc) Nothing here to help you determine how effective or ineffective your QMS is. 5. If you have more than one process approver (Risk, CA’s, NC’s etc) and one of them approves the action the other approvers cannot go back and make changes. Your locked out. I had myself and one other person approving a risk and the other approver approved the risk and I could not make any changes. I had to delete the entire risk action and start over. 6. Only exports to CSV files not Excel .xlsx extensions 7. Internal audit module - build a schedule only. No prefilled forms to use, no form development capabilities.

The software is outstanding, the support is quick, and thorough. The QT9 team has worked with multiple departments in our organization. From our internal IT group working to setup connections to other platforms, to the implementation team members and document admins as they have been introduced. The support has been consistent and so very much appreciated.

Intuitive, friendly user interface, the well thought out connections from one module to another. The fact that each module is included and not ala carte is a HUGE benefit. The online training academy is one of the best I have used.

A lot of filters that just take a bit of getting used to. Sometimes they default and employees need a little extra coaching to make sure they are loading the view they need.

We are moving towards a complete integration with QT9 QMS to eliminate a lot of our paper and Excel processes. Having interlinked modules (for example, being able to create NCs directly from inspection results) saves time and improves efficiency. Overall it's a very good platform for a company who needs to jump into a one-stop QMS solution.

The product is easy to implement because of the built-in world class workflows. You do not need to map your current processes into QT9 - you use the built-in process workflows, and the workflow and tab interface is consistent across the modules. This makes deployment easy, because once people are familiar with the interface they can learn other modules easily. You can focus on how to *use* the software, and not spend valuable time trying to *configure* it.

QT9 is very responsive to feature requests and bug fixes. We have provided several suggestions that are being considered to improve usability. I guess the think I like least is that I didn't start using it sooner.

Before using QT9 data gathering and analysis was difficult at best. Now we have the ability to analyze data in order to make real changes to the quality of our processes and products.

Easy to set up and use, yet very powerful reporting capabilities. As the administrator I can add users, structure drop down menus, etc. myself and don't have to rely on outside sources.

Nothing currently comes to mind, but this is because QT9 asks their customers to submit feature requests for improvement ideas.

Our company appreciates all of the quality functions like document control, corrective action, audit, management review, supplier management, and training.

I like the modularity of the system. This really helps helps with implementation, and ease of use. I appreciate the stops built into the system to ensure important aspects are included in these records.

New product tracking would help our processes (APQP, Quoting tracking). Reporting isn't great for training, not good at summary information.

Our company had no Quality Management System at all before QT9. Some of the employees were relucted to try something new, but all got on board when they saw how easy it was to use. All through the entire ISO 9001:2015 process from the very beginning to certification all the Auditors really thought it was a well designed package geared towards the ISO 9001:2015 process.

The Document Control module was the most used and was very easy to implement and maintain.

That you could not upload video files, that the file size was limited. But this was not really an issue.

We were able to implement and deploy the system to our users very quickly. The sales team have been very quick with responses and follow up.

This is a very easy to implement software that is inexpensive. The workflows are great out of the box.

The only con I have at this time is the reporting on Change Control. Once they develop reporting for this feature, it will be a big improvement.

QT9 QMS Software is helping to facilitate the

Training, Documentation Control, ISO Functions, Calibration and Equipment, Supplier and Customer Management, Safety, Corrective/Preventive Action Modules are all great and very useful. Implementation was amazing and the support/ training given allowed us to get our system up and going within a couple months.

The FMEA / Risk Management Module could use some help. I wish the modules tied together better.

The document control feature has improved our ability to find documents and some records when requested for audit or project purposes. Training is much easier to manage than our old process of paper, binders, and spreadsheets. I like being able to link equipment and gages to system documentation in the Document list. The customer service has always been helpful and responds quickly. There has been very little unscheduled system downtime and when it happens, is usually resolved quickly. Especially after this last year with the pandemic, we were able to keep some processes moving uninterrupted and we're now looking forward to using additional modules over the coming year, including CAPA, Audits, NCP, and Supplier Controls.

We've been using the Document Control and Training Modules for just over two years. Both are fairly intuitive and fit in pretty well with what we had previously been doing on paper and with spreadsheets. Within the last year, we began using the Calibration and Maintenance modules and our teams seem happy with them as well. I like the ability to create unlimited "user-defined fields" to tailor some of the modules more to how my company does things.

I would like to see the ability to add employees, or at least job titles, to the Document Request record so they can be reviewed and added/updated prior to full document approval and training record generation. This would be especially handy for new documents. Right now, we have to wait until a document is published to assign to job titles. Either that, or when an employee is evaluated by the manager in the training record, there could be a pop-up that asks "do you want this added to the employee's job title?"

Overall, QT9 has been a solid software for us to centralize our documentation, calibration, CARs and SCARs. It's made presentation during our ISO audits easier, as well as helping us to identify gaps in our documentation.

1. Ability to capture and track information during the Corrective Action Process. It's never lost due to the Timeline feature. 2. Revision history stored electronically on all documentation makes it easy to understand why documents were updated. 3. Easy to teach new employees how to use. A "learn by use" system that has extensive training modules/support.

Some modules, like MRB, have too many required fields. Can make the process of red tagging suspect material time consuming. For printing documents, should be able to customize the layout by drag-and-drop to fit only what you need on one page (CARs, Projects, MRB tags, etc). For example, I may not need all the Additional Information fields for a CAR (WO, PO, Lot, etc), so I should be able to remove them from the printed pdf report just by dragging the field out of the preview page.

The customer training and support offered (at no extra cost!) made the implementation from our paper based systems to QT9 software nearly stress free. We now have a transparent QMS system that drives consistany, ownership, and continual improvement. It has been a key system to achieving and maintaining our compliance to ISO 9001:2015. I can't say enough about what a great partner QT9 has been and continues to be in supporting our QMS.

We spent a solid 6 months searching for QMS software that would be a best fit for our company. QT9 was an easy choice when stacked up against 'big name' programs. It is a user friendly platform, highly configurable, provides transparency to all levels of our organization, reasonable pricing, amazing customer service/support, and you get the entire system- no extra cost to implement or customize a new module.

The training module is too rigid and maintenance heavy for our training and documentation needs.

Overall I have to say the training module is by far my favorite. Going from paper in a folder and getting everyone trained and signed off and then having to scan training to files was very time consuming. Now with a few clicks of the mouse training is sent to those who need it with the documents attached, they sign electronically and training records are created in the system. Fast and easy.

This software is very user friendly and easy to use. The help feature and QT9 academy are very easy to follow instructions for anything you are working on in the system. It is very easy to use the , modules and being able to be paperless is awesome especially in the medical device area. Set up for users is extremely fast an simple. Getting reports is fast and accurate.

Honestly I find all the pop ups every time you do a function a bit overkill, especially if you are doing a lot of entering of new documents. It would be nice if they could shut off this feature. I do wish there was an automatic email alert that when to users a email when they are overdue on training, or a CAR element.

Initially only used as a repository for documents. Once expanded to using other modules we were impressed especially since it streamlined the Quality Admin process made being audited easier and faster.

Easy to use / Good way to handle standard quality functions and also make it auditor friendly / enhances quality organization productivity by eliminating paper driven steps and having information in one place instead of a myriad of files / Requires very little training to learn / Well organized ? Good uptime / Secure, reliable server and security.

For RELATED FILES wish an easier way to input documents such as emails or email attachments without needing to save in a temporary file or desktop / Way for Administrator to set the standard grid layout as default then let people do individual customization instead of only a system default / Need to be able to upload more items instead of just customers, suppliers, documents. For example CARS, Complaints etc so that when shifting ot QT9 can use existing data.

For a small company this sw package has all the basic offerings. We are a medical device company and myself, the FDA & ISO auditors liked the traceability, control of documents and everything was there at our fingertips from Management review to Documents to CAR's. Qt9 is always responsive to our questions and resolving issues. They have incorporated some of our suggestions into their sw updates. It is intuitive to new users and easy to use. We have configured their ECR module to handle storage of documents and electronic signoff for Validation Protocols,Reports, Design review meetings, Stop & Resume Ships, and other processes that need sign-off in addition to its ECR capability. For the cost, the flexibility, electronic signature and traceability is worth trying out the system.

One of the items on our wish lists is to be able to limit daily emails to weekly for some people. The common complaint is that people don't look at them (deleting) because a notification appears every day. Training module is a little inflexible, but they are looking at improving it and also improving the report outputs.