QMS at ENergon Labs

Robust Quality Management System implemented and enforced by a completely independent and competent QA Team with ultimate authority

QMS complaint to cGMP , 21 CFR Parts 210 and 211, ICH Q7 and Q10, PICS, ISO 17025 and Schedule L1 of Drugs and Cosmetics Act.

Change management system with change management committee,
CAPA system with CAPA review and management committee,
Data review process with complete audit trail for electronic and paper based data Deviation mechanism
OOS handling system with scientific hypothesis testing and root cause analysis
Training programs with metrics, matrix and skill upgradation programs.
Internal Quality Audits with Audit Review Committee
Quality Risk Management of all key processes