Quality Assurance

Our robust QA framework reflects our commitment to data integrity, regulatory compliance, and the ethical conduct of clinical trials—providing sponsors and stakeholders complete confidence in the study data generated.

Our QA Commitment:

  • Promote a culture of quality throughout the organization
  • Ensure trial data verification against the protocol, SOPs, GCP, and regulatory requirements
  • QA as integral part of every system, process & activity
  • Maintain a comprehensive Quality Management System (QMS) with verifiable procedures
  • Conducts audits to ensure ongoing compliance
  • Client-facing QA team to track action items
quality-assurances

Monitoring & Compliance:

  • Support quality through robust observations and CAPA implementation
  • Request and review monitoring reports to track observations and implement CAPA
  • Collaborate closely with monitors and Principal Investigators (PIs) to verify observations and document responses
  • Adhere strictly to IRB reporting requirements, and ensure observations are addressed appropriately

Root Cause Analysis (RCA) & CAPA:

We approach non-compliance as a system failure, not a person failure. Through Root Cause Analysis (RCA), we:

  • Intend to identify the issue and underlying systemic weakness
  • By eliminating the root cause, not only addressing the observations
  • Use RCA as the foundation for effective CAPA

CAPA Best Practices:

  • Define “SMART” CAPAs  with clear action plan, ownership, due dates and built-in effectiveness checks
  • Corrective Actions:  Correcting the error with appropriate documentation and notification
  • Preventive Actions:  Devising and implementing an additional step to ensure similar errors do not happen across the organization or sites

At Tupalin Research, quality isn't an afterthought.