QT9 Quality Management

Puntos a favor: 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.

Contras: 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.

Comentarios: Our biggest problem with the legacy programs were solved by using QT9, by having control over all requirements of our quality system registrar. All users (123 people) have been polled with a 98% positive response.

Puntos a favor: I like most that our ISO 9001:2015 certified quality management systems are now in one (software) place. We no longer need to create and store our documentation, audits, suppliers, inspections, change control, risk assessment , calibration, projects, management review, corrective actions in multiple locations and formats.

Contras: Query / search features are limited and not made to be used intuitively.

Comentarios: We are a tiny manufacturing company. Recent audits for a large and valuable customer have driven the need to develop our Quality Management System. QT9 was the only reasonably priced option that didn't make me pick upfront which handful of modules I might need. I still haven't started using everything QT9 has to offer but my CAPA and Customer Feedback programs are robust and well documented. The automatic emails to designated "Responsible Parties" seemed to really please my last auditor. I even use it for my Safety Incidents/Investigations.

Puntos a favor: You get all the modules that are available at the time of purchase, plus your software gets upgraded to include future awesomeness as they develop it. It's pretty intuitive, but what it lacks there, it makes up for in the abundant training and help options. The staff is very hands on and knows the product intimately. The launch process was relatively easy and well handled. A sandbox site allows you to work out how you'll implement the system before cluttering it up with your first attempts. All that and relatively inexpensive.

Contras: Not all the modules may be a perfect fit for how you'll use the software. You may have to be creative or maintain some documentation outside the software.

Comentarios: Overall a very good value for the price.

Puntos a favor: Easy to use, all of the modules are integrated to one another, fast setup / configuration. the support that you receive from QT9 is always fast and effective.

Contras: The software cannot be customized to your exact needs. It is not possible to change the name of modules or tabs within the system or to hide ones that your facility does not use.

Puntos a favor: For CARs, the information is all in one convenient location.
The Employee Training location allows us to attach documents (we keep Curriculum Vitae in the Related Files section). This allows for a one-stop-shop when audited on employee training and experience.
Vendor has been incredibly interactive and helpful when we have had questions/concerns. Also provided requested on-site training that met our expectations and timeline.

Contras: Unable to perform 'text' searches. For example, performing a search within the Master File attachments for a term or other document number is not available.
In addition, I create training records for new hires; the content and attributes are always the same. It would be helpful if I could copy an existing record.
As part of the Quality organization, I notice grammatical errors. QT9 has several messages that contain mis-spellings.