Quality Management Systems (QMS)

A next-generation AI integrated Quality Management System designed by clinical QA experts — enabling compliance, clarity, and confidence across every phase of your trial operations.

At ClinAura, we believe that quality is not a checkpoint — it is a system, a culture, and a commitment woven into every process. A well-designed Quality Management System (QMS) forms the backbone of clinical and regulatory compliance, ensuring every activity is traceable, auditable, and aligned with international standards.

Our approach to QMS development is built on the principles of precision, integrity, and insight, helping organizations transition from compliance-driven operations to a proactive culture of quality excellence.

Core Components of ClinAura QMS

1. Quality Governance and Leadership

Strong leadership defines the direction of quality. Governance structures establish accountability, oversight, and strategic alignment of quality goals across all operational levels.

2. Document and Data Control

A central pillar of QMS, document control ensures that SOPs, work instructions, and records are accurate, approved, version-controlled, and readily accessible. Proper data management upholds data integrity (ALCOA+) principles.

3. Risk Management Framework

Risk-based thinking drives smarter decisions. Through systematic identification, assessment, and mitigation, potential issues are addressed before they escalate into findings — supporting the principles of Quality by Design (QbD).

4. Training and Competency Management

A QMS is only as strong as the people who implement it. ClinAura emphasizes continuous learning through training programs that build competency, awareness, and accountability across teams.

5. Deviation, CAPA, and Change Management

Effective handling of deviations and change ensures that lessons learned translate into improvement. Our QMS approach integrates CAPA systems that prevent recurrence and strengthen process robustness.

6. Audit and Self-Inspection Program

Internal audits and self-inspections act as the pulse check of quality. Regular, objective assessments help identify trends, ensure readiness for external inspections, and foster continual improvement.

7. Supplier and Vendor Quality Oversight

Ensuring that external partners meet the same standards of excellence is key to maintaining data integrity and patient safety. Vendor qualification and ongoing performance reviews are integral to the QMS framework.

8. Continuous Quality Improvement (CQI)

Quality is a journey, not a milestone. ClinAura’s QMS model embeds CQI practices, using metrics, feedback loops, and performance indicators to drive sustained excellence.

Why ClinAura QMS- Where Intelligence Meets Integrity

ClinAura QMS is a next-generation quality management solution engineered for GxP-regulated industries. It unifies every quality function — from audit planning to CAPA execution, supplier qualification to risk control — enabling organizations to visualize the true health of quality in real time.

Key Differentiators:

• Real-time Compliance Health Dashboard – instantly see your organization’s QMS health score, trending metrics, and critical hotspots.

• AI-Driven Insights – intelligent prompts identify overdue actions, emerging risks, and process bottlenecks.

• Integrated CAPA, Audit, and Training Management – designed for 21 CFR Part 11 compliance and ICH E6 (R3) alignment.

• Predictive Risk Radar – anticipate compliance dips before they occur.

• Seamless User Experience – elegant interface, responsive on every device, built for busy QA teams.

Real-Time Visibility into Quality

Your Organization’s Pulse, Visualized.

From the moment you log in, ClinAura QMS tells your story in data — not guesswork.

• ClinAura QMS Health Summary: A composite index tracking audits, CAPAs, and risk performance across the enterprise.

• Hotspot Analytics: Instantly spot weak links — such as overdue audits or high-severity risks — before they impact compliance.

• Regulatory Readiness Heatmap: Live scoring of each QMS domain on readiness percentage and criticality.

• Predictive Compliance Radar: Visualize how audits, risks, and CAPAs interact to indicate your quality maturity.

The Intelligence Layer

AI that Thinks Like an Auditor

The built-in AI Insights engine continuously monitors key metrics and recommends prioritized actions —

"6 overdue audits detected. Prioritize these today."
"1 critical risk active. Ensure mitigations are tracked."
"Supplier qualification audit pending."

Your QMS now talks to you — guiding decisions with precision and foresight.

About ClinAura QMS

What Makes ClinAura QMS Different from others?

Built by Auditors, for Quality Leaders

ClinAura QMS is not just a software platform — it’s a digital quality ecosystem crafted by professionals who understand the nuances of GxP, ICH-GCP, and global regulatory expectations.
From document control to CAPA, from training compliance to inspection readiness — ClinAura QMS embeds Quality by Design into every process.

Key Differentiators

🔹 Risk-based, audit-ready architecture

🔹 Modular dashboards for each QMS component

🔹 AI-powered insights and real-time compliance health score

🔹 Smart reminders, escalations, and dynamic audit trails

🔹 Integrated analytics showing organizational quality trends

Real-Time Quality Metrics

Your Organization’s Pulse — in One Dashboard

• 📊 Quality Health Index — A composite view of organizational compliance.

• 🔍 Regulatory Readiness Gauge — See how ready you are for the next inspection.

• 📈 Trend Analytics — Identify recurring non-conformities, training gaps, and audit hotspots.

• ⏱️ Real-time Performance — Every action, approval, and closure logged instantly.

The ClinAura Edge

From Insight to Action — Instantly

• Predictive Quality Intelligence: AI identifies potential risks before they become findings.

• Seamless Integration: Plug into existing CTMS, TMF, or LMS ecosystems.

• Data Integrity by Design: Secure, validated, 21 CFR Part 11-compliant.

• Accessible Anywhere: Web, mobile, or tablet — same experience, same assurance.