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Quality & Compliance Glossary
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Quality & Compliance Glossary
Designed for pharmaceutical manufacturers transitioning from manual systems to structured eQMS environments.
1. Data Integrity & Governance
Data Integrity
Audit Trail
ALCOA & ALCOA+
21 CFR Part 11
Audit Trail
2. Documentation & Records
Document Control
3. Quality Culture
Internal Audit
Complaint Handling
4. Investigation & Risk
Deviation
Risk Management (ICH Q9)
Change Control
CAPA – Corrective and Preventive Action_new
CAPA – Corrective and Preventive Action
5. Core GMP Systems
Validation
Training Management
