SimbaWare QMS for process design and management

ONE solution for all of your quality system needs in a regulated environment

SIMBAWARE electronic QMS offers a large array of processes which cover all elements of a robust quality system including: Document Management, Design Control, Risk Management, Purchasing Controls, Production and Process Controls and other Requirements.

  • Process applications are created from pre-configured process models which can be used as is or modified to match your process requirements.
  • Pre-configured process models are intended to reduce the time to go live and to share industry best practices.
  • Our process models benefit from the multiple generations of quality management systems our team has developed and deployed in medical device companies across the globe.

Simple and Intuitive Process Editor

Our web-based process editor allows customers to modify pre-configured process models or to create new process applications from scratch. Process owners are now able, without the help from IT, to update and maintain their processes like adding or changing data fields, modifying notifications, configuring new dashboards and much more.

SIMBAWARE Process Editor

Built-in Dashboards and Reports

One of the significant advantages of moving to an electronic system is the availability of data. We believe that most process improvements originate from well-selected performance indicators. Our dashboards not only provide instant feedback to the user, but help to align the organization on common goals by connecting the dashboards with the objectives of the company. Process owners can determine which company dashboards each user will see; each user can add any additional dashboards they’d like to view.

SIMBAWARE User Dashboard

Developed and Operated in the Cloud

SIMBAWARE uses the latest cloud technology. This technology includes OAuth 2.0 for authentication as well as encrypted transactions using strong ciphers with FIPS 140-2 support. Databases were selected to provide the scalability and performance needed for large enterprise installations.  SIMBAWARE QMS is built on Microsoft Azure which provides the scale and security of a global cloud provider. By utilizing Microsoft Azure SIMBAWARE is also able to pass savings to customers because of the shared hosting environment. This is one of the many ways we are trying to keep SIMBAWARE QMS affordable for customers.


Successful System Implementation

Moving from a paper based system to a state of the art electronic system requires not only technical preparation but also cultural preparation for the organization. After several years of deploying quality management systems we have created the C4 Method™.

The C4 Method includes:

  • Culture Preparation – Helping the team to understand how the electronic system will impact their work. Show them the system features to understand how they can help themselves to deliver better results and be more motivated to do so.
  • Certification of Process Owner – our goal is to give the power of the system to the process owner. Therefore we have created training courses for process owners to learn about system features and how to apply them to create ideal process applications.
  • Configuration of Process Applications – we are eager to get our customers up and running on SIMBAWARE QMS quickly. Our large array of pre-configured process models can be used out of the box or quickly modified to match the customers’ processes.
  • Customer Paced – we understand that every customer is different. Selecting the first process application and making it a full success is one of the most critical achievements in a system implementation project. We provide broad support to help customers achieve this critical milestone. After the first process application is launched the team goes back to work on the next one – Configure – Launch – Repeat – at a pace which is right for the customer.

Ready to learn more?

Pls contact us for more information about our solution and how you can get started.

213 SW Columbia St.
Bend OR, 97702