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:
