All MatrixALM and MatrixQMS features.

Features available in:
ALM & QMS
QMS
ALM
Core Features
Marketplace Modules
Marketplace Plugins
Marketplace Templates
Templates Predefined & Configurable
Documents & Reports
Security
Intranet
REST API and Integrations
Regulatory

Core Features

Integrated risk management

Requirements, specifications and use cases can be captured. Risks can be defined according to customizable templates and formulas. Risk mitigations can be defined. Configurable for different risk assessment methodologies and risk levels.

QMS
ALM
Test Module

Test cases can be defined and tests can be planned and executed in multiple test cycles.

ALM
SxMD Templates

Develop software as/in a Medical Device (SxMD) with an off-the-shelf structured eQMS using audit-ready templates aligned with EU and US standards that ensure compliance.

Learn more

QMS
ALM
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.
QMS
ALM
Live Traceability Verification

The user interface will indicate if the traceability is broken, missing or outdated.

QMS
ALM
Hierarchical Data Structure
All design items are stored in a tree structure.
QMS
ALM
Full Text Search
Allows you to use search strings to find items. The item tree can be filtered to show only matching items.
QMS
ALM
File Attachments
Files are stored using secure keys, and shareable securely without user authentication.
QMS
ALM
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.
QMS
ALM
Item Preview
Preview referenced items or the item links in the tree by hovering the mouse over them with shift pressed.
QMS
ALM
Item Categories

MatrixALM can be easily configured to describe any Design Input and Design Output categories.

ALM
Item Structure

Each item category can have different fields and hold values. Like, rich text, dropdown, tables, etc...

QMS
ALM
Unique Item Links

Each design item, report, or controlled document has a unique link, like a website. This link can be embedded in other documents or emails allowing others with access to the project to directly access the item.

QMS
ALM
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.

QMS
ALM
Session Comments

Several changes to the project can be logged under the same change comment without re-entering it for every change.

QMS
ALM
Compliant electronic signatures

Sign documents electronically. Full support for compliance with FDA 21 CFR part 11 for electronic records including electronic signatures.

QMS
ALM
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.

QMS
ALM
Time Zone and Date 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.

QMS
ALM
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.

ALM
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.

QMS
ALM
Cross Project References

Reference any item in other projects.

QMS
ALM
XML Export

All project data including audit trail can be exported as xml.

QMS
ALM
Excel Support

Database items can be exported as xlsx files.

QMS
ALM
Tool validation package

Complete validation documentation, ISO 13485 and ISO 27001 certification, and a pre-populated project that you can use to validate your configuration (e.g. the risk analysis formulas). The same project can also be used to efficiently validate other tools that require validation.

QMS
ALM

Marketplace Modules

Review

Quickly perform and document design and quality process reviews.

QMS
ALM
Compose

Supercharge product development & maintain traceability. Get more products out the door & combine existing items from projects for reuse in other projects.

Learn more

QMS
ALM
Branching & Merging

Develop, test, and deploy faster. Increase productivity by enabling teams to work on multiple product releases in parallel, fix bugs, and work on prototype ideas without affecting the main codebase.

Learn more

ALM
Variants/Labels

Labels can be set for each category. 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.

QMS
ALM
Group Management

This module helps you administer big groups of users, in order to more easily assign access rights to projects.

QMS
ALM
Single Sign-On & 2FA

Multiple single sign-on provider options.

QMS
ALM
Agile Sync Module

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.

QMS
ALM
Translation Module

AI based translation of individual fields into another language.

QMS
ALM

Marketplace Plugins

Copy/Paste Fields

Copy and paste content from field(s) in an item to other items.

QMS
ALM
Print Table Sorter

The Print Table Sorter enables you to select the parameters you want to sort the table by so that you can quickly present data in a meaningful way.

QMS
ALM
Trace Details Dashboard

A detailed view of project traceability at the category level for up traces and down traces.

QMS
ALM
User Group Table

See user access and group access for all users and groups regardless of your user type in this dashboard.

QMS
ALM
Copy Children to Folders

Copy a selection of item(s) to one or more folders simultaneously.

QMS
ALM
Bulk Field Copy

Copy one field into multiple items in a project.

QMS
ALM
Remove Empty Tables

Automatically remove empty tables in your printed documents.

QMS
ALM
Trace Graph Dashboard

Check traces with this interactive trace dashboard that visualizes the interrelation of your traces.

QMS
ALM
Add Links in the Help Menu

Create hot links to common sites your team needs to access directly in the help menu.

QMS
ALM
Hide/Show Fields Based on Value

Show or hide a field or hide one field and show another at the category level with a checkbox status.

QMS
ALM
Risk Panel

Risk dashboards to see detailed information for your risk matrix and RBM and RAM stats.

QMS
ALM
Set Label on Save

Automatically add “dirty” labels in down-traces when an item is modified.

QMS
ALM
ReLink

Import Microsoft Excel data while keeping traces and external links.

QMS
ALM
Automatic Review

Create review packets for different review types per category to make requesting reviews as easy as two clicks directly from the item.

QMS
ALM

Marketplace Templates

Non-Conformity Management and CAPAs

Manage and link Complaints with Non-Conformities and CAPAs. Needs Variants/Labels module.

QMS
ALM
Supplier Management for ALM

Manage your critical and non-critical supplier criteria to prove your supplier diligence for the ALM essential package.

ALM
Lean QMS

Clean and simple QMS structure without template procedures or risks. Needs Variants/Labels module, Needs Reviews module.

QMS
Calibration

Manage and monitor the calibration of equipment and tools. Needs Variants/Labels module.

QMS
ALM
Software V-Model

A sample project with a software V-model for software development with SOUP category.

ALM
Macro Process Layers

A publishable QMS structure with macro process layers and a global training layer. Needs Variants/Labels module, Needs Reviews module.

QMS
Simple V-Model

A sample project with a simple V-model for software development with two layers of design input and output.

ALM
Roles and Job Descriptions

An HR project to manage roles, job description and training.

QMS
Structured Standards List

Structure of different standards, regulations, and guidelines that are publicly available.

QMS
Hardware and Software Project Structure

An example project structure for a combined product using both hardware and software. Needs Variants/Labels module, Needs Reviews module.

ALM
Supplier Management

Manage your critical and non critical supplier criteria to prove your supplier diligence. Needs Variants/Labels module.

QMS
Audit and CAPA

Consolidate Audit categories with their related CAPAs. Needs Variants/Labels module.

QMS
Change Control

Manage change controls with approval workflows. Needs Variants/Labels module.

QMS
ALM
Compliant Management

Collect and manage complaints compliantly. Needs Variants/Labels module.

QMS
Calibration and Preventative Maintenance

Manage and monitor calibration and preventive maintenance of equipment. Needs Variants/Labels module.

QMS

Templates Predefined & Configurable

Document Templates

You can setup document templates, and share them for use in other projects.

QMS
ALM
Project Templates

You can create reusable project templates to get you started quickly if you have multiple similar projects. Each project is based on a template which defines the design items that should be managed, how the traceability is set up and which risk module should be used.

QMS
ALM
ISO 13485 Processes Template

Predefined templates with traceability mapped out to standards to get started. Adapt them according to your own company details.

QMS
eQMS and Procedures & SOP Management Project

Generate and publish a digital Quality Manual of your company’s internal procedures and all related training procedures.

QMS
Human Resources Records Project

Store roles, staff, and training records in a dedicated database.

QMS
Word Templates

Can be customized.

QMS
ALM
Controlled Document Templates

Define default templates for new controlled documents.

QMS
ALM
SxMD Templates

Audit-ready flexible templates that dynamically pull data from Matrix into the templates with full traceability to all the standards that govern them.

Learn more

QMS
ALM

Documents & Reports

Change Summary Report

All changes done in a given period can be shown. Reports and documents can be creates as html, word, pdf or excel for custom tables

QMS
ALM
Project Analysis Reports

Analyze the content and traceability of projects, perform test planning and execution, design reviews, risk assessment etc. Reports have links directly into the project for quick access to issues. Reports and documents can be created as html, word, pdf, or excel for custom tables.

QMS
ALM
Custom Reports

Custom reports can be created to export your data the way you need it. Reports and documents can be created as HTML, word, pdf or excel for custom tables

QMS
ALM
Custom Documents

Custom documents can be created to export your data the way you need it. Reports and documents can be creates as html, word, pdf or excel for custom tables

QMS
ALM
Controlled Documents

Documents can be built like building blocks and are connected to the project. Sections can be automatically populated with the latest project data. Each controlled document can be frozen at any time. Define default templates for new controlled documents. Reports and documents can be created as HTML, word, pdf or excel for custom tables

QMS
ALM
Document Archive

Unlimited documents can be archived.

QMS
ALM

Security

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.

QMS
ALM
Frontend

HTML 5 Client (compatible with latest Chrome, Safari, Firefox, Edge at time of release). Chrome recommended for best user experience.

QMS
ALM
HTTPS

Multi user access through a web application with a secure access protocol. Check our certificates here.

QMS
ALM
Access Control

Define user rules per project.

QMS
ALM
Passwords

Password aging and required password strength can be configured.

QMS
ALM

Intranet

System Requirements

Ask us for the current requirements for the OS, database, and web server.

QMS
ALM
Installation Services
Installation and backup configuration offered as service.
QMS
ALM
Backups
Instructions for backing up databases can be provided.
QMS
ALM

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.

QMS
ALM
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.

QMS
ALM
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.

Regulatory

Internal audit services

Simplify your path to ISO 13485 certifications with our tailored internal audits. Whether online or onsite, our certified auditors leverage in-depth Matrix expertise to efficiently enhance your Quality Management System.

Learn more

QMS
ALM
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!

QMS
ALM
ISO 27001

Information security management systems. Our company is also ISO/IEC 27001:2022 certified.

QMS
ALM
Core Features
Integrated risk management

Requirements, specifications and use cases can be captured. Risks can be defined according to customizable templates and formulas. Risk mitigations can be defined. Configurable for different risk assessment methodologies and risk levels.

Test Module

Test cases can be defined and tests can be planned and executed in multiple test cycles.

SxMD Templates

Develop software as/in a Medical Device (SxMD) with an off-the-shelf structured eQMS using audit-ready templates aligned with EU and US standards that ensure compliance.

Learn more

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.
Live Traceability Verification

The user interface will indicate if the traceability is broken, missing or outdated.

Hierarchical Data Structure
All design items are stored in a tree structure.
File Attachments
Files are stored using secure keys, and shareable securely without user authentication.
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
Preview referenced items or the item links in the tree by hovering the mouse over them with shift pressed.
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 and hold values. Like, rich text, dropdown, tables, etc...

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.

Session Comments

Several changes to the project can be logged under the same change comment without re-entering it for every change.

Compliant electronic signatures

Sign documents electronically. Full support for compliance with FDA 21 CFR part 11 for electronic records including electronic signatures.

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.

Time Zone and Date 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

Reference any item in other projects.

XML Export

All project data including audit trail can be exported as xml.

Excel Support

Database items can be exported as xlsx files.

Tool validation package

Complete validation documentation, ISO 13485 and ISO 27001 certification, and a pre-populated project that you can use to validate your configuration (e.g. the risk analysis formulas). The same project can also be used to efficiently validate other tools that require validation.

Marketplace Modules
Review

Quickly perform and document design and quality process reviews.

Compose

Supercharge product development & maintain traceability. Get more products out the door & combine existing items from projects for reuse in other projects.

Learn more

Branching & Merging

Develop, test, and deploy faster. Increase productivity by enabling teams to work on multiple product releases in parallel, fix bugs, and work on prototype ideas without affecting the main codebase.

Learn more

Variants/Labels

Labels can be set for each category. 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.

Group Management

This module helps you administer big groups of users, in order to more easily assign access rights to projects.

Single Sign-On & 2FA

Multiple single sign-on provider options.

Agile Sync Module

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.

Translation Module

AI based translation of individual fields into another language.

Marketplace Plugins
Copy/Paste Fields

Copy and paste content from field(s) in an item to other items.

Print Table Sorter

The Print Table Sorter enables you to select the parameters you want to sort the table by so that you can quickly present data in a meaningful way.

Trace Details Dashboard

A detailed view of project traceability at the category level for up traces and down traces.

User Group Table

See user access and group access for all users and groups regardless of your user type in this dashboard.

Copy Children to Folders

Copy a selection of item(s) to one or more folders simultaneously.

Bulk Field Copy

Copy one field into multiple items in a project.

Remove Empty Tables

Automatically remove empty tables in your printed documents.

Trace Graph Dashboard

Check traces with this interactive trace dashboard that visualizes the interrelation of your traces.

Hide/Show Fields Based on Value

Show or hide a field or hide one field and show another at the category level with a checkbox status.

Risk Panel

Risk dashboards to see detailed information for your risk matrix and RBM and RAM stats.

Set Label on Save

Automatically add “dirty” labels in down-traces when an item is modified.

Automatic Review

Create review packets for different review types per category to make requesting reviews as easy as two clicks directly from the item.

Marketplace Templates
Non-Conformity Management and CAPAs

Manage and link Complaints with Non-Conformities and CAPAs. Needs Variants/Labels module.

Supplier Management for ALM

Manage your critical and non-critical supplier criteria to prove your supplier diligence for the ALM essential package.

Lean QMS

Clean and simple QMS structure without template procedures or risks. Needs Variants/Labels module, Needs Reviews module.

Calibration

Manage and monitor the calibration of equipment and tools. Needs Variants/Labels module.

Software V-Model

A sample project with a software V-model for software development with SOUP category.

Macro Process Layers

A publishable QMS structure with macro process layers and a global training layer. Needs Variants/Labels module, Needs Reviews module.

Simple V-Model

A sample project with a simple V-model for software development with two layers of design input and output.

Roles and Job Descriptions

An HR project to manage roles, job description and training.

Structured Standards List

Structure of different standards, regulations, and guidelines that are publicly available.

Hardware and Software Project Structure

An example project structure for a combined product using both hardware and software. Needs Variants/Labels module, Needs Reviews module.

Supplier Management

Manage your critical and non critical supplier criteria to prove your supplier diligence. Needs Variants/Labels module.

Audit and CAPA

Consolidate Audit categories with their related CAPAs. Needs Variants/Labels module.

Change Control

Manage change controls with approval workflows. Needs Variants/Labels module.

Compliant Management

Collect and manage complaints compliantly. Needs Variants/Labels module.

Calibration and Preventative Maintenance

Manage and monitor calibration and preventive maintenance of equipment. Needs Variants/Labels module.

Templates Predefined & Configurable
Document Templates

You can setup document templates, and share them for use in other projects.

Project Templates

You can create reusable project templates to get you started quickly if you have multiple similar projects. Each project is based on a template which defines the design items that should be managed, how the traceability is set up and which risk module should be used.

ISO 13485 Processes Template

Predefined templates with traceability mapped out to standards to get started. Adapt them according to your own company details.

eQMS and Procedures & SOP Management Project

Generate and publish a digital Quality Manual of your company’s internal procedures and all related training procedures.

Human Resources Records Project

Store roles, staff, and training records in a dedicated database.

Word Templates

Can be customized.

Controlled Document Templates

Define default templates for new controlled documents.

SxMD Templates

Audit-ready flexible templates that dynamically pull data from Matrix into the templates with full traceability to all the standards that govern them.

Learn more

Documents & Reports
Change Summary Report

All changes done in a given period can be shown. Reports and documents can be creates as html, word, pdf or excel for custom tables

Project Analysis Reports

Analyze the content and traceability of projects, perform test planning and execution, design reviews, risk assessment etc. Reports have links directly into the project for quick access to issues. Reports and documents can be created as html, word, pdf, or excel for custom tables.

Custom Reports

Custom reports can be created to export your data the way you need it. Reports and documents can be created as HTML, word, pdf or excel for custom tables

Custom Documents

Custom documents can be created to export your data the way you need it. Reports and documents can be creates as html, word, pdf or excel for custom tables

Controlled Documents

Documents can be built like building blocks and are connected to the project. Sections can be automatically populated with the latest project data. Each controlled document can be frozen at any time. Define default templates for new controlled documents. Reports and documents can be created as HTML, word, pdf or excel for custom tables

Document Archive

Unlimited documents can be archived.

Security
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

Define user rules per project.

Passwords

Password aging and required password strength can be configured.

Intranet
System Requirements

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.
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.

Regulatory
Internal audit services

Simplify your path to ISO 13485 certifications with our tailored internal audits. Whether online or onsite, our certified auditors leverage in-depth Matrix expertise to efficiently enhance your Quality Management System.

Learn more

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!

ISO 27001

Information security management systems. Our company is also ISO/IEC 27001:2022 certified.