Akitra Andromeda® EQMS – Your Intelligent, Agentic AI-Powered Partner in Quality Management

Akitra Andromeda® Enterprise Quality Management System (EQMS), powered by Agentic AI, is built for fast-moving, regulated teams who want to stop managing quality with spreadsheets and start driving it with intelligence.

Why Akitra Andromeda® EQMS

Designed for modern compliance teams, built for real-world challenges, powered by Agentic AI; Akitra Andromeda® EQMS streamlines document control, incident resolution, engineering change tracking, and regulatory reporting, all within a single, secure, and easy-to-use platform. With flexible access controls, real-time collaboration, and intelligent automation, Akitra Andromeda® simplifies the complex world of quality management.

Key Capabilities That Set Akitra Andromeda® Apart

Document Management

No more version chaos. Akitra Andromeda® EQMS lets you easily upload, categorize, and manage SOPs, manuals, and quality records in formats like PDF, DOC, or XLS—while automated review and approval workflows, role-based access control, 21 CFR Part 11-compliant e-signatures, and complete version history with audit trails keep everything compliant, secure, and audit-ready.

Incident Management

Capture, investigate, and resolve incidents in real time—with zero spreadsheets. Akitra’s intelligent incident management module automatically triggers workflows, assigns owners, and tracks resolution progress so nothing slips through the cracks.

CAPA Management

Akitra’s CAPA (Corrective & Preventive Actions) engine does more than capture issues—it guides root cause analysis, assigns tasks, triggers notifications, and ensures full traceability across incidents, audits, and ECOs.

Requirements Management

Whether you’re building to FDA, ISO, or internal specs, Akitra Andromeda® gives you a centralized place to define, track, and validate all your quality and regulatory requirements.

FDA 510(k) Readiness

Akitra® helps med-tech companies prepare, organize, and track everything needed for FDA 510(k) submissions. No more scrambling for evidence or documentation.

Travelers (Digital Routing & Traceability)

Track every step of your product lifecycle digitally. Akitra’s Travelers module replaces manual paperwork with real-time visibility, digital routing, and production traceability.

FAQ's

What is an EQMS and how does Akitra Andromeda® stand out?

An Enterprise Quality Management System (EQMS) helps organizations manage quality processes, documentation, and compliance. Akitra Andromeda® EQMS goes further with Agentic AI automation, intuitive workflows, and deep integration with regulatory frameworks—making quality management seamless and scalable.

Is Akitra Andromeda® EQMS suitable for regulated industries like healthcare or manufacturing?

Absolutely. Akitra Andromeda® EQMS supports standards like ISO 9001, FDA 21 CFR Part 11, and more—making it ideal for life sciences, medtech, manufacturing, and other heavily regulated sectors.

Can I track Engineering Change Orders (ECOs) and CAPAs within the system?

Yes. Akitra Andromeda® EQMS offers built-in modules for ECO tracking, CAPA management, and audit readiness—with full traceability, automated workflows, and effectiveness tracking.

How long does it take to implement Akitra Andromeda® EQMS?

Implementation timelines vary based on your needs, but Akitra’s platform is designed for rapid deployment—with pre-built templates, expert onboarding, and easy integration with your existing tools.