What is OneQA?
OneQA is a software platform that enables automated workflows for testing of biomedical devices. Designed as a cloud-connected desktop application, OneQA provides tools to customize and execute test procedures, generate traceable reports, and collaborate effectively within a team and organization. With decades of in-house expertise in healthcare compliance built-in, support for a range of Fluke Biomedical test equipment, and a robust and growing procedure library available out-of-the-box, conducting testing to compliance has never been faster or easier.
Who should use OneQA?
OneQA is designed to assist biomedical technicians, medical device manufacturers, and quality specialists conduct preventive maintenance, acceptance testing, and quality assurance testing. With ever-growing numbers of medical devices to build, test, and maintain, OneQA provides a more efficient and sane way of managing a hectic workload, helping you conduct fast and accurate testing, minimize risk, and comply with regulations and accrediting agencies.
Which automated tests can OneQA perform?
OneQA currently automates:
- electrical safety tests supported by ESA612, ESA614, ESA615, and ESA620
- defibrillator and pacemaker tests supported by Impulse 6000D and Impulse 7000DP
- ventilator tests supported by VT650 and VT900/VT900A (excluding anesthesia tests)
The test devices are interoperable with OneQA as is. No additional plug-ins or licenses are required to automate these devices, all that's needed is to keep their firmware versions up-to-date.
Additional devices will become supported in upcoming releases.
Can OneQA integrate with third-party applications, such as CMMS?
Yes. The OneQA API can be leveraged to interface with third-party applications, including most CMMS platforms. Integration has already been demonstrated on popular platforms including Maintenance Connection and MediMizer.
Can I use OneQA while offline?
Users can execute test procedures and collect results while offline. However, some features require an internet connection, so features such as synchronizing data with other users or authoring test procedures are disabled offline.
What are the minimum system requirements for the desktop application?
- Windows OS: 8.1 and 10 (32- and 64-bit)
- RAM: 4 GB
- HD space: 1 GB
- Screen resolution: 1024x768
- .NET framework: 4.7.2
- USB port: at least one is required for connection to supported test devices
Administrator privileges are required to install and update the desktop application. Furthermore, the following URL endpoints must be accessible through your network firewall:
What is the licensing portal?
The OneQA Licensing Portal is where product licenses are administered and teams (a.k.a. tenants) and team members are configured for collaboration within OneQA. Through a tenant dashboard, additional users can be invited to the tenant and their permissions configured by assigning them roles.
What is a tenant?
A tenant in OneQA is a team, department, or location that contains multiple users who wish to collaborate. The tenant synchronizes data between all its members, including procedures, assets, test results, test devices, etc.
What are the different user roles?
A Tenant Admin can purchase licenses, invite or remove tenant members, modify member roles, and edit the tenant details.
An Application Admin can modify member roles.
An Approver can approve or reject test results.
An Author can create or edit procedures, create or edit report templates, and edit test device information.
A User can create or edit asset information, execute procedures, and generate test reports.
How does OneQA compare to Ansur Test Automation Software?
Both Ansur and OneQA are tailored to automate the workflows of medical test professionals.
OneQA is cloud-connected, has an intuitive user interface, is supported by a customer success team, and will continue to add functionality in future releases.
Ansur is a standalone installation that currently supports a wider range of Fluke Biomedical test devices, including patient simulators and gas flow analyzers.
Where is my data stored?
Your data will be stored on the Amazon Web Services (AWS) cloud on servers in the USA and Europe. AWS is an industry leader in meeting the requirements of the most security-sensitive organizations. For more information, visit the AWS security page.
We backup in the same AWS Region. We will not move or backup customer content outside of this region without customer consent, except if legally required and as necessary to maintain our services in case of disaster recovery or force majeure.
We use best practices for global privacy and data protection to help you operate securely within OneQA. These security protections and control processes are independently validated by third-party independent assessments.
We use strong encryption for the content in transit and at rest. These features include:
- Data encryption capabilities available in AWS storage (S3 Amazon Simple Storage Service) and database service (RDS Amazon Relational Database Service).
- AWS Key Management to secure access to our APIs.
How does OneQA classify customer data?
OneQA classifies customer data into two categories: customer content and account information.
We define account information as information about a customer that a customer provides to us in connection with the creation or administration of a customer account. For example, account information includes names, usernames, phone numbers, email addresses, and eventually billing information associated with a customer account. The information practices described in the Fluke Privacy Notice apply to account information.
Who controls customer content?
Customer maintain ownership of their content. We do not access or use customer content for any purpose without customer consent. We never use customer content or derive information from it for marketing or advertising.
As a customer, you maintain full control of your content and responsibility for configuring access to OneQA service and resources. We provide an encrypted access to our login secured customer portal for Access Management. We do not access or use your content for any purpose without your consent. We never use your content or derive information from it for marketing or advertising.
We do not disclose customer information unless we're required to do so to comply with a legally valid and binding order.
For further reading, view the OneQA Knowledge Base.