QT9 QMS

Highly customizable and efficient eQMS

Comments: 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.

Pros:

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.

Cons:

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.

QT9 QMS

Comments: 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.

Pros:

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.

Cons:

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.

Alternatives Considered: Ennov Quality Suite, Greenlight Guru, Ideagen Quality Management, TrackWise and MasterControl Quality Excellence

Reasons for Switching to QT9 QMS: QT9 was validated by the vendor, compliant with ISO 9001, ISO 13485, and FDA 21CFR 211-210 and 820. It had the critical QMS functions that our organization required, including management review. It also did not require the involvement of an IT department or a significant implementation effort. Compared to other systems that we evaluated, it provided the most features for the best cost.

Limited Flexability

Comments: 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.

Pros:

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.

Cons:

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.

Very robust program that centralizes and manages essential QMS & EMS processes and outputs.

Comments: 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.

Pros:

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.

Cons:

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.

Alternatives Considered: ETQ Reliance and MasterControl Manufacturing Excellence

Reasons for Choosing QT9 QMS: Lack of support for existing platform. Failing infrastructure that no longer fits our business needs.

Reasons for Switching to QT9 QMS: We liked that QT9 is all inclusive and we would not have to plan for costly add-ons and prolonged integration and implementation. QT9 allows you to work at your own pace and implement the modules one at a time, or more. For example, we chose to implement document control and training and have engaged the entire organization in which module they would like to see implemented next.

QT9 is a fantastic QMS tool

Comments: 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.

Pros:

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.

Cons:

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.

Alternatives Considered: Microsoft SharePoint, TrackWise and MasterControl Quality Excellence

Reasons for Switching to QT9 QMS: Multi-site, fully featured, great pricing for concurrent licensing, and out-of-the-box usability made QT9 the best choice for our company.