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Aligned Elements

Aligned eQMS
Aligned Elements

Intelligent Design Control Management for medical device companies, driving correct, consistent, and compliant Technical File and DHF creation.

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Requirement Management

Capture and control requirements with a complete, chronological audit trail of all events.

Risk Management

ISO 14971 risk assessments. Identify, evaluate, mitigate, implement and verify all risks.

Test Management

Plan, execute, monitor and document hardware and software Verification and Validation activities.

Traceability Management

Let the traceability drive your design quality. Consistent and connected end-to-end tracing.

Document Management

Streamline document creation and approvals with electronic signatures and document routing.

Consistency and Completeness

Find and fix inconsistencies in seconds. Spot gaps before audits do.

Regulatory Compliance

Built for medical compliance to always be complete, correct and audit-ready.

Integrations

Connect Aligned Elements to your existing ecosystem of applications for a unified workflow.

Aligned eQMS

Unite medical device quality, regulatory and development teams and ensure compliant quality, maximizing efficiency with minimal administration.

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Document Control Management

Easy-to-use, secure and compliant document management.

Training Management

Ensure and document employee competence. Demonstrate compliance at any time.

Change Management

Change happens. Change drives you forward. You are prepared.

Quality Event Management

Feedback, Complaints, Nonconformities, CAPAs and Vigilance reporting.

Supplier Management

Select, approve, manage and monitor suppliers in a single location.

Audit Management

Confidently demonstrate compliance with organized, traceable audit planning.

Equipment Management

Track maintenance, calibrations, controls and repairs for all your important equipment.

Computer Software Validation Management

Assess, control and manage CSV data for full compliance.
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Support Documentation

User Manuals and Guides that give you control

Common Questions

Quickly find answers to frequently asked questions

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Access and download installation executable for On-premise deployment

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Discover what’s new and learn about recent features

System Requirements

Minimum and Recommended Server and Client Requirements

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We understand that security is critical. We act accordingly.

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Company News

Biocartis selects Aligend Elements for Design History File Management

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