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1. 1. Glossary

QMS & EHS Glossary

Key terms in quality management, life sciences, and compliance — organized A–Z and searchable for quick reference.

Search glossary terms

A

Adverse Event Reporting Analytical Method Validation Approval Workflow Automated CAPA Audit Readiness Artificial Intelligence in Quality Audit Management

B

Batch Records Batch Release Benchmarking Biocompatibility Testing Biopharmaceutical Compliance Business Continuity Management

C

CAPA (Corrective and Preventive Action)Change Control Management Calibration Management Clinical Quality Assurance (CQA) Complaint Handling Computer System Validation (CSV) Compliance Management Customer Complaint Investigation

D

Design Control Device Master Record (DMR)Device History Record (DHR)Deviation Management Document Control Data Integrity Design Verification and Validation

E

Environmental Monitoring Equipment Calibration EHS Compliance Electronic Batch Record (EBR) Employee Competency Management Escalation Workflow Enterprise QMS Integration

F

Failure Mode and Effects Analysis (FMEA)FDA 21 CFR Part 11 Compliance Field Safety Corrective Action (FSCA)First Article Inspection (FAI)Functional Risk Assessment Follow-up Corrective Action

G

Good Automated Manufacturing Practice (GAMP 5)Good Clinical Practice (GCP) Good Distribution Practice (GDP)Good Documentation Practice (GDP) Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP)Global Regulatory Compliance

H

Hazard Analysis and Critical Control Points (HACCP)Health and Safety Management Human Factors Engineering High-Risk Product Assessment HIPAA Compliance Historical Data Review

I

Incident Management Internal Audit ISO 13485 Certification ISO 9001:2015 Compliance IQ/OQ/PQ Validation In-Process Quality Control (IPQC)Investigational Product Management

J

Job Qualification Justification Report Jurisdictional Audit Just-in-Time Documentation

K

Kaizen (Continuous Improvement)Key Performance Indicator (KPI)Key Quality Attribute (KQA)Key Risk Indicator (KRI)Knowledge Transfer Protocol

L

Lab Equipment Calibration Labeling Compliance Lifecycle Management Lot Traceability Lean Manufacturing Lessons Learned Database Laboratory Information Management System (LIMS)

M

Management Review Material Compliance Medical Device File (MDF) Medical Device Reporting (MDR)Metrics Dashboard Monitoring Plan Manufacturing Quality Assurance Microbial Testing 

N

Nonconformance Management (NCM)Nonconforming Product Control Nonconformance Report Notice of Event (NOE)New Product Introduction (NPI) Networked QMS Platform

O

Operational Excellence OEE (Overall Equipment Effectiveness)Out-of-Specification (OOS)Out-of-Trend (OOT) Organizational Change Management Onboarding Compliance Outsourced Supplier Quality 

P

Preventive Maintenance Process Validation Product Lifecycle Management (PLM) Performance Qualification (PQ)Post-Market Surveillance (PMS)Production Part Approval Process (PPAP) Periodic Review Predictive Analytics in Quality 

Q

Quality Management System (QMS)Quality Assurance (QA)Quality Control (QC)Quality Culture Quality Metrics Dashboard Quality Planning Quality by Design (QbD)Quality Risk Management (QRM)

R

Root Cause Analysis (RCA)Regulatory Compliance Risk Assessment Recall Management Record Retention Policy Regulatory Inspection Readiness Risk-Based Thinking Remediation Plan 

S

Supplier Quality Management (SQM) Statistical Process Control (SPC)Standard Operating Procedure (SOP) Safety Data Sheet (SDS)Sterilization Validation System Validation Software as a Medical Device (SaMD) Sample Management 

T

Training Management System (TMS)Traceability Matrix Test Method Validation Technology Transfer Total Quality Management (TQM)Third-Party Audit Technical File Compliance

U

User Acceptance Testing (UAT) Unplanned Deviation User Access Control Utilization Rate Upstream and Downstream Quality Control Unexpected Event Handling 

V

Validation Master Plan (VMP) Verification and Validation (V&V) Vendor Qualification Vendor Audit Visual Inspection Validation Lifecycle Value Stream Mapping 

W

Workflow Automation Work Instruction Control Waste Reduction Warranty Management Workplace Safety Compliance Work Order Management 

X

X-bar Chart (Statistical Control)XML Data Integration eXtended Quality System (XQS) X-ray Inspection System Cross-Functional Validation 

Y

Yield Optimization Yearly Product Review (YPR)Yellow Belt (Lean Six Sigma) Year-over-Year Audit Comparison Yoke Fixture Testing 

Z

Zero Defect Strategy Zero Harm Policy Z-score Analysis Zone Classification (Cleanroom)Zero Tolerance for Noncompliance 

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