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Description

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools. The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities. Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

Description

Enterprise software to improve business agility. objectiF RPM features include portfolio, requirements, test and risk management. UML/SysML diagrams allow you to visualize requirements, goals, and processes. You can also manage backlogs at different levels (from business use case, user story), plan taskmanagement with Kanban boards and run queries across multiple projects. This allows you to collaborate with distributed teams using one source of information. The software can be customized to meet your corporate needs. It is flexible, extensible, and integrable. It provides templates for agile and mixed project management, digitization programs, and projects following Scaled Agile Framework®, SAFe.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Apache Subversion Yes 
Azure DevOps Server Yes 
GitHub Yes 
GitLab Yes 
Jira No 
Jira Align Yes 
Microsoft Excel No 
Microsoft Project No 
Microsoft Visio No 
Microsoft Word No 
Redmine Yes 

Integrations

Apache Subversion No 
Azure DevOps Server No 
GitHub No 
GitLab No 
Jira Yes 
Jira Align No 
Microsoft Excel Yes 
Microsoft Project Yes 
Microsoft Visio Yes 
Microsoft Word Yes 
Redmine No 

Pricing Details

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Yes 
Free Version No 

Pricing Details

129 €/month/concurrent user
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Vendor Details

Company Name

microTOOL

Founded

1984

Country

Germany

Website

www.microtool.de/en/products/objectif-rpm/

Product Features

Application Lifecycle Management

Administrator Level Control Yes 
Defect Tracking Yes 
Iteration Planning No 
Project Management No 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA Yes 
Automated Test Generation Yes 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Product Features

Application Lifecycle Management

Administrator Level Control No 
Defect Tracking Yes 
Iteration Planning Yes 
Project Management Yes 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Enterprise Architecture

Application Portfolio Management No 
Architecture Governance Yes 
Capability Mapping No 
Diagramming No 
Idea Management No 
Modeling & Simulation Yes 
Project Management Yes 
Risk Assessment No 
Transformation Roadmapping No 
Version Control Yes 

IT Project Management

Bug Tracking Yes 
Issue Management No 
Milestone Tracking Yes 
Percent-Complete Tracking Yes 
Portfolio Management Yes 
Prioritization Yes 
Product Roadmapping Yes 
Requirements Management Yes 
Resource Management Yes 
Status Tracking Yes 
Supports Agile Yes 
Supports Scrum Yes 
Task Management Yes 
Testing / QA Management Yes 
Time & Expense Tracking Yes 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control Yes 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management Yes 
Corrective Actions (CAPA) No 
Dashboard Yes 
Exceptions Management No 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment Yes 

Test Management

Automation Integration No 
Collaboration Tools Yes 
Pass/Fail Results Tabulation No 
Reporting / Analytics Yes 
Requirements Management Yes 
Test Scheduling No 
Test Tracking Yes 
Time/Budget Tracking Yes 

Workflow Management

Access Controls/Permissions Yes 
Approval Process Control No 
Business Process Automation No 
Calendar Management No 
Compliance Tracking Yes 
Configurable Workflow Yes 
Customizable Dashboard Yes 
Document Management Yes 
Forms Management Yes 
Graphical Workflow Editor Yes 
Mobile Access No 
No-Code No 
Task Management Yes 
Third Party Integrations No 
Workflow Configuration Yes 

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