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Description
Efficiently collect, create, approve, and oversee requirements for intricate systems throughout the complete project lifecycle. Ensure seamless synchronization and effortless access to all Polarion data through a fully browser-based platform. Foster immediate communication among analysts, engineers, QA personnel, and DevOps teams through threaded discussions, wikis, notifications, alerts, and more. Successfully navigate audits, compliance checks, or regulatory inspections with traceability that is straightforward to implement and assured through automatic change control of each requirement. Oversee work items and documents through workflows that dictate how and when they transition from one state to another based on customizable rules, complete with comprehensive audit trails, electronic signatures, and security measures. A unique feature, Polarion LiveDocs, allows for concurrent and secure collaboration on specification documents, ensuring that every paragraph is distinctly identifiable and traceable, thereby enhancing team productivity and accountability. This approach not only streamlines processes but also elevates the quality and reliability of project outcomes.
Description
Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.
We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.
We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.
API Access
Has API
API Access
Has API
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
LDRA Tool Suite
QVscribe
Redmine
SureView
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
LDRA Tool Suite
QVscribe
Redmine
SureView
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€1300 per year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Siemens
Founded
1847
Country
Germany
Website
polarion.plm.automation.siemens.com/products/polarion-requirements
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
Product Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes