QUALITY AT LAMBDA

 

Committed to deliver quality and regulatory compliant clinical trial services in a professional, efficient, timely and cost-effective manner while protecting patient safety and data integrity for regulatory submissions

Quality Management System Oversight

 

  • Defined CAPA process to ensure identification, analysis, resolution, tracking and closure of issues, while lessons learned are used for continuous improvement.
  • 21 CFR Part 11 compliance for applicable computer systems and IT infrastructure including risk-based Validation according to a controlled SDLC.
  • Documented Business Continuity and Disaster Recovery plans
  • Measured and Effective Training System operating on KirkPatrick Training principles

 

Quality Assurance

 

  • Internationally accreditated Quality team
  • Practices principle of Risk based Audits
  • Conduct regulatory inspections and client audits
  • Process harmonization across global locations
  • Quality Review Board Meetings (QA updates to senior management to ensure visibility and resolution of issues)

 

Aim to achieve Business Process Excellence

 

  • Continuous analysis of existing processes to make them electronic, integrated and simplified
Regulatory Track Record

 

Lambda has an impressive track record with various international regulatory agencies including US-FDA, EMA, WHO, ANVISA (Brazil), MHRA (UK), TGA (Australia), POLISH, ANSM (France), AGES (Austria), OGYI (Hungry), Turkey (MoH), TPS (Canada), Thailand (MoH) and DCGI. Please see a summary of the inspections faced across various regulatory agencies below:

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