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Aligned Elements assists medical device companies in developing innovative products efficiently. Their flagship software, Aligned Elements, is a requirements management tool that helps create, manage, and trace design control items in the design history file (DHF) while ensuring regulatory compliance.
The Smyte Score is a weighted average from leading review sites across the web.
Comprehensive Traceability and Documentation:
Users appreciate how Aligned Elements enables seamless linking of requirements from business needs to user needs, through design and development processes, including hazard analysis and verification. This comprehensive traceability simplifies regulatory submissions and enhances audit readiness.
Integrated Risk Management:
The software’s built-in risk management module, supporting ISO 14971-compliant assessments like FMEA, is highly valued. It allows users to connect risk analysis points directly with affected requirements, streamlining the risk management process.
Responsive Customer Support:
Users commend Aligned Elements for its excellent customer support, noting quick and personalized assistance. The team is described as responsive and helpful, addressing issues promptly and providing solutions efficiently.
User Interface Complexity:
Some users find the user interface challenging to navigate initially, especially for those not using the software daily. The learning curve can be steep, and more intuitive guidance would be beneficial.
Limited Collaboration Features:
While the software offers traceability and documentation features, some users report limitations in team collaboration functionalities. The absence of features like concurrent editing or advanced commenting can hinder collaborative efforts.
Customization and Configuration Challenges:
Users have noted that setting up and configuring the software to align with specific organizational processes can be complex. The database-like workflow may be difficult to manage without proper setup, and usability during daily use can be affected.
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