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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
API Access
Has API
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
Integrations
Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine
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
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
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
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