Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Compile and organize Action Items that stem from compliance mandates, audit results, incidents, and other occurrences, while offering real-time insights into compliance levels and EHS performance metrics. The Completion Scorecards enable site leaders to assess their team's effectiveness and pinpoint which positions are heavily burdened with work. By utilizing interactive dashboards and filters, Corporate EHS leaders can analyze trends and uncover compliance deficiencies across various facilities and regulatory sectors. Customized regulatory profiles for each site ensure that compliance strategies are consistently precise and current. Compliance Calendars and dashboards outline both completed tasks and upcoming deadlines, and task details provide information on any changes to related regulations. The Action Items feature includes connections to pertinent citations, audit inquiries, and event specifics, creating a reliable knowledge repository that delivers context for your teams. Furthermore, email alerts keep accountable individuals updated, while event logs meticulously track all modifications, making it evident who executed each action. This comprehensive approach not only enhances accountability but also fosters a culture of continuous improvement in compliance and performance management.
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.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Apache Subversion
No
Azure DevOps Server
No
GitHub
No
GitLab
No
Jira Align
No
Redmine
No
Integrations
Apache Subversion
Yes
Azure DevOps Server
Yes
GitHub
Yes
GitLab
Yes
Jira Align
Yes
Redmine
Yes
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
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
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Dakota Software
Founded
1988
Country
United States
Website
www.dakotasoft.com/proactivity-suite/tracer
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
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
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