We will be happy to help you get started in generating faultless technical documentation using our extensive range of services – such as user or validation package training. Learn more about our optional services:
Get to know the full scope of BAYOOSOFT Risk Manager as part of an intensive 30-day TRIAL. Download the approval accelerator now and activate your test environment – with no obligation!
Do you need a basic introduction to aspects of validation or would you like to keep the internal costs of software validation as low as possible? Our team of validation experts will be happy to support you with handling the pre-validation package and take care of specific adjustments for your company.
Naturally, we will also help with the implementation of projects – such as onboarding your staff. Compose your own individual service package from our extensive range of services.
Whether seeking ideas for a product innovation, planning development or coordinating the approval strategy – correctly classifying the medical device is important and indeed also complex.
To simplify this step, we have developed an app that quickly and reliably classifies your medical device.
Download our new app from the app store now:
All systems involved in the process need to be validated in accordance with DIN EN ISO 13485:2017. BAYOOSOFT Risk Manager has a validation process based on the GAMP 5 guidelines for computerized validation according to these requirements and is validated as category-four software.
BAYOOSOFT Risk Manager is based on a concurrent user model and promotes cross-location collaboration of users in companies thanks to multi-user access. Users access the SQL server via the network connection. Information and data are recorded centrally on this SQL server and stored in an auditable manner.
You can install the BAYOOSOFT Risk Manager client on end user PCs in the company as often as required. Only the users concurrently working in the system are counted as licenses.
As an essential component of the technical documentation for medical devices, risk management provides the foundations of the validated approval accelerator. Depending on the type of your medical device, this can be expanded with various additional modules.
| Hardware: | Processor/CPU: min. 1.5 GHz dual core Working memory: min. 1 GB RAM Graphics resolution: min. 800×600 (recommended: min. 1280×1024) Hard disk space: 150 MB for Risk Manager + .NET framework (32bit: 880 MB / 64bit: 2 GB) |
| Operating systems: | Windows 8.1 Windows 10 |
| Required software components: | Microsoft .NET 4.8 Framework Windows Installer 4.5 MSQL Native Client 11 |
If the required software components do not exist on the client, they will be automatically installed during installation.
| Hardware: | Processor/CPU: min. 2 GHz dual core Working memory: min. 4 GB RAM Hard disk space: min. 1,5 GB (data volume of the standard database after installation: approx. 200 MB) |
| Operating systems: | Windows Server 2012 / 2016 / 2019 |
| Required software components: | SQL Server 2012 or higher |
If an existing SQL Server is used, it needs to run in the authentication mode “mixed mode” to permit an SQL-integrated user registration.
Is BAYOOSOFT Risk Manager validated?
BAYOOSOFT Risk Manager is validated according to ISO 13485. Based on the GAMP 5 guidelines for computerized validation, the market-leading software solution was validated as category-four software and successfully passed all aspects – from the requirements and configuration specifications through to the acceptance test. To simplify the validation process, we offer a pre-validation package with all necessary documents
Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?
The reports generated in BAYOOSOFT Risk Manager can be submitted to designated bodies in Europe as well as the FDA in accordance with FDA 21 CFR Part 11. The software solution meets the requirements of the guideline through the specific system settings in the application, with the three criteria “Apply Password Rules”, “Use Audit Trail” and “Use Digital Signature”.
What is the knowledge database and what advantages does it offer?
The integrated knowledge database allows synergies to be used and reduces loss of knowledge associated with staff turnover. Continuously developing a knowledge platform allows efficient, cross-project work. When creating new elements, BAYOOSOFT Risk Manager recognizes whether they already exist in the same or other projects or in the knowledge database and automatically suggests them. This prevents redundant data and enables cross-project knowledge transfer. CSV imports are also available.
Working with the knowledge database takes place in template management and the user must be assigned the right “Define Templates” or role “Template Manager” to this end.
Suggestion lists can support you by providing frequently recurring elements for preparing a new risk analysis. They help contribute to utilizing company knowledge as efficiently as possible. Groups are used as suggestion lists for new elements in the analysis program section.
Groups are managed depending on the device type. For this reason, you first always need to select the desired device type in the corresponding list fields.
Does the system include content-based rights management?
BAYOOSOFT Risk Manager includes fine-grained user and role management, which meets the requirements of MDR 2017/745 and implements content-based rights management. Depending on the role, users can be assigned certain rights. As a team member of individual project versions, the rights of this global configuration are adopted, but can still be individually adjusted in each project version. The standard roles are as follows:
Roles and rights are managed in the administration area / user management or role management and can be further specified for individual projects if needed.
What does “inherit rights” mean in a project?
If you have placed a checkmark for “inherit rights”, the rights indicated in the administration area under user management will be assigned automatically. To issue rights to a user that deviate from those entered in the administration area, remove the checkmark on the project team page and click on the user. The rights available will then be displayed and can be adjusted accordingly for the opened project.
After installing the software, I am asked for my user name and password. How can I register in the system?
The risk analyses prepared using BAYOOSOFT Risk Manager can contain sensitive company data. For this reason, access to the system is protected by user registration. In order to test the software, the following demo users are provided with the installation:
Demo user – project management:
User name: sieber
Password: peter
Demo user – administration:
User name: admin
Password: admin
What import and export options does the system offer?
All project versions of BAYOOSOFT Risk Manager can be exported and imported for conversion into QRM4e format. In addition, numerous import functions via CSV or Excel are available – such as requirements templates.
How do I activate our full license?
If you have purchased a full license of BAYOOSOFT Risk Manager, you can either carry out a new installation or update your existing test version. In the case of a new installation, the registration form appears directly after opening the system. For test versions, you can do so by clicking on the BAYOOSOFT Risk Manager logo in the top left and then “Register”.
You can enter your license key in the “Full Version” area in the registration form. Then click on “Activate full version”. Following activation, you can find the license information for your company under “License Details”.