Quality Assurance

We have an independent and dedicated Quality Assurance team committed to work transparently and proactively in all aspects of the audit processes during a clinical trial to ensure that the services delivered as a Central Reference Laboratory consistently meet sponsor and regulatory requirements. The dedication and competence of our Quality Assurance team, combined with knowledge of inspection agencies' and sponsors' expectations means that the risks associated with the pre-analytical, analytical and post analytical laboratory processes during a Clinical Trial are identified, assessed and managed professionally and well in time.

• Continuous monitoring of the Quality Indicators
• Robust business continuity and disaster recovery plan
• Elaborate Computer System Validation
• Regular study specific audits conducted by in-house QA auditors
• Extensive method validations
• Continual improvement plans
• Risk management
• Periodic management review meetings
• Compliance with the SOPs, accreditation/applicable GxP guidelines, GCLP, latest Biomedical waste management rules
• Adherence to the training calendar
• Satisfactory lab performance in IQC and EQAS ensure audit readiness at all times
• Regular monitoring and audits enable early detection of potential problems and implementation of appropriate CAPA
• Successfully faced 40+ vendors & sponsors audit including various sponsor audits such as NABL etc