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Kvalitetsstyringssystemer (QMS)

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Threeqa is a QMS and ALM platform for medical device and regulated life-science teams. Built around IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 11 workflows, it helps teams manage requirements, risks, design outputs, tests, documents, and audit trails in one connected system.

With dynamic traceability, impact analysis, risk management, document control, and hash-chained audit trails, Threeqa reduces manual compliance work and gives engineering, QA, and regulatory teams a clearer path from development to verification evidence.

Threeqa kan findes i Quality Management Systems (QMS) kategorier.

De produkter, der ligner Threeqa mest, er:

Kure Forfremmet → Aligned Elements → Unifize → Scigeniq →

Skærmbilleder

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Detaljer

Threeqa Hovedfunktioner

• Impact Analysis
  See which requirements, risks, tests, or documents are affected by a change.
• Risk Management
  Identify hazards, evaluate risks, define controls, and track residual risk.
• QMS + ALM Platform
  Manage quality, development, risk, and verification work in one connected system.
• Traceability Graph
  Visualize how requirements, risks, design outputs, tests, and documents are connected.
• Data Ownership & Export
  Export your data when needed and avoid being locked into a closed system.
• Requirements Management
  Capture, organize, review, and link product and software requirements.
• Standards-Based Workflows
  Support workflows aligned with IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 11.
• Test & Verification Management
  Link verification activities directly to requirements, risks, and evidence.

Threeqa fordele

• Better Risk Visibility
  Track hazards, risk controls, evaluations, and residual risk throughout development.
• Faster Impact Analysis
  Quickly understand what may be affected when a requirement, risk, test, or document changes.
• Improved Audit Readiness
  Maintain structured records, version history, approvals, and audit trails in one place.
• Reduced Tool Fragmentation
  Centralize QMS and ALM workflows instead of relying on separate files and tools.
• Less Manual Compliance Work
  Replace disconnected spreadsheets, documents, and manual traceability work with one system.
• Stronger Team Collaboration
  Give engineering, QA, regulatory, and management teams a shared source of truth.
• Clear End-to-End Traceability
  See how requirements, risks, tests, design outputs, and documents are connected.
• More Reliable Verification Evidence
  Link tests and verification activities directly to requirements and risk controls.

Hvem bør bruge Threeqa?

• QA Managers
  Quality teams managing controlled processes, documentation, reviews, and audit readiness.
• Risk Managers
  Users responsible for hazard analysis, risk controls, evaluations, and residual risk tracking.
• Project Managers
  Project leads who need visibility into compliance status, dependencies, and open gaps.
• Systems Engineers
  Teams connecting user needs, system requirements, risks, design outputs, and verification.
• Software Engineers
  Engineers managing requirements, implementation links, testing, and change impact.
• Medical Device Teams
  Teams developing regulated software, hardware, or combination products.
• Regulatory Affairs Teams
  RA teams preparing and maintaining evidence for standards and regulatory submissions.
• Verification & Validation Teams
  Teams planning, executing, and linking tests to requirements, risks, and evidence.

Badges

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Threeqa Alternativer

Kure Forfremmet

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Unifize

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Scigeniq

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