Features
Requirements Management
Requirements, specifications and use cases can be captured.
Risk Module
Risks can be defined according to customizable templates and formulas. Risk mitigations can be defined.
Test Module
Test cases can be defined and tests can be planned and executed in multiple test cycles.
Traceability
Traceability between items can be set up as optional or required. By default, several traces must exist, e.g. from requirements to specifications and test cases.
Predefined or Customizable Project Templates
Each project is based on a template which defines the design items that should be managed with Matrix Requirements products, how the traceability is set up and which risk module should be used.
Hierarchical Data Structure
All design items are stored in a tree structure which allows to organize them in way to easily find them.
Full Text Search
Allows you to find any item based on search strings. The item tree can be filtered to show only matching items.
Live Traceability Verification
If the traceability is broken or suspicious, i.e. a trace is missing or outdated the user interface will directly indicate this.
File Attachments
Can be made in any text control or special file attachment sections, in all categories possible. Files are stored using secure keys, allows to share the files securely without user authentication (like sharing a dropbox file)
Full Item History
All changes to items are logged and can be seen in the items history or the project wide activity log. Revisions of items can be compared to see quickly what changed.
Item Preview
Referenced items can be previewed without leaving the current item by hovering the mouse with shift pressed over the referenced item or the item links in the tree.
Change Summary Report
All changes done in a given period can be shown.
Session Comments
Several changes to the project can be logged under the same change comment without re-entering it for every change.
Unique Item Links
Each design item, report or controlled document has a unique link, like a web-site. This link can be embedded in other document or email allowing other to directly access the item. (if they are granted access to the project).
Project Analysis Reports
Reports can be used to analyze the content and traceability of projects, to perform test planning and execution, design reviews, risk assessment etc. Reports have links directly into the project allowing to quickly fixing issues.
Controlled Documents
Documents can be built of building blocks, like audit trails, signatures boxes etc. They are connected to the project and can have sections which are automatically populated with the latest project data. Each controlled document can be frozen at any time.
Document Templates
You can setup document templates, release them and use them in other projects.
Document Archive
Unlimited documents can be archived.
Electronic Signatures
Archived documents can be signed electronically.
Stale Object Warnings
If a user works on an item which has been modified by someone else, it will be indicated in the user interface.
Item Review Workflow
You can set up a workflow to mark items with a review flag. A change to the item can automatically reset this flag.
Variants (Labels and Filters)
It is possible to define labels which can be attached to items of a given item category, for example test cases could be marked as smoke or regression tests or both, or requirements as being important for FDA, CE or both. The tree and reports can be filtered by these labels.
Time Zone and Formatting
Projects have a central time zone and date time formatting which is used by all team members and reports. The user interface of each team member can be adjusted to their location and date time formatting preferences.
JIRA Clouds Plug-in
Issues related to any item can be tracked in JIRA clouds. Issues found during testing can be added and are automatically linked to the executed test cases.
Smart Text Blocks
You can define pre‐defined text blocks like a version number or the intended use, which can be inserted as macros in rich text fields.
Cross Project References
Allow to reference any item in other projects.
Project Templates
You can create reusable project templates to get you started quickly if you have multiple similar projects.
Regulatory
FDA 21 CFR part 11
Full support for compliance with FDA 21 CFR part 11 for electronic records including electronic signatures. Ask us for a gap analysis.
ISO 13485
Quality management system for the design and manufacture of medical devices and requirements for regulatory purposes. Our company is
EN ISO 13485:2016 certified so we do know what this is all about!
FDA CFR part 820
Quality System Regulations.
IEC 62304
Medical device software – software life cycle process.
IEC 82304
Health software -- Part 1: General requirements for product safety.
IEC 62366
Application of usability engineering to medical device.
ISO 14971
Application of a risk management system for medical devices.
ISO 27001
Information security management systems. Our company is also
ISO/IEC 27001:2013 certified.
Technology Stack & Specification
Data Centers
We have servers in the US, in Canada, UK, Germany, France, India, and Australia. You can choose where we install your Matrix Requirements instance.
Alternatively, we can discuss special needs or requests, and we can install our application also on Google Cloud, Microsoft Azure, etc.
Frontend
HTML 5 Client (compatible with latest Chrome, Safari, Firefox, Edge at time of release). Chrome recommended for best user experience.
HTTPS
Multi user access through a web application with a secure access protocol.
Check our certificates here.
Access control
User roles per project - Access Control Lists to define who can change which field in which project.
Passwords
Password aging and required password strength can be configured.
XML export
All project data including audit trail can be exported as xml.
Excel export
Database items can be exported as xlsx files.
Reporting and Documents
Reports and documents (html, word and pdf) are created using xslt 2. Custom xslt can be provided for document generation.
Intranet Version
System Requirements
Please ask us for the current requirements for the OS, database, and web server
Installation Services
Installation and backup configuration offered as service.
Backups
Instructions for backing up databases can be provided.
Configuration Options
Item Categories
MatrixALM can be easily configured to describe any Design Input and Design Output categories.
Item Structure
Each item category can have different fields, to hold values: rich text, dropdown, tables, etc...
Reports
Custom or modified reports can be added. Reports are simple xslt transformation of the project’s data.
Word Templates
can be customized.
Controlled Documents
It is possible to define default templates for new controlled documents.
Risk Module
The risk module can be configured to use different risk assessment methodologies and risk levels within.
Test Module
can be configured to offer different test results for individual test steps and rules how to compute the overall result from the test step results.
Traceability Rules
It can be configured which traces between items can or must exist.
Variants/Labels
It is possible to define which labels can be set for each category.
REST API and integrations
REST API
We have a documented
REST API that our customers can use to access our application
all functions can be achieved through the REST API.
Built-in integrations
Matrix Requirements products can be configured to integrate with:
With all these, you can create a ticket in the external service directly through Matrix, to notify your coworkers they have a bug to fix or some work to do on specifications. The ticket will be linked both ways to the Matrix item, allowing for a great traceability between Matrix and the ticketing system.
Agile Sync clients
If you wish to keep some of the source of truth outside of Matrix Requirements, we can set up the synchronization (requirements, tests, ...) from the following external services:
- Confluence (Clouds or server)
- Team Foundation Server
- GitHub
- Zephyr for JIRA (through ZAPI)
- Pivotal Tracker
- JIRA (Clouds or server)
Creating a new converter is quite easy, we can easily do others or explain you how to use our Java template to create a new one yourself.
Documentation and Support
User Manual
Our User Manual is
here.
Administration Guide
Administration and configuration is explained
here.
Support
We are very proud to provide one of the fastest support on the planet. Reach us through our
JIRA service desk portal here.
Here is our satisfaction report over the last year (stars / 5):
