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Glossary

Definitions of terms and regulations related to Quality in the Life Science Industry

 

A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   W  X  Y  Z  #

A

ALCOA

 

C

CAPAs

cGMP

Change Control

Clinical Data Management (CDM)

Compliance

Continuous Improvement

Corrective action

Cost of Quality (CoQ)

Cost of Poor Quality

Critical Control Point (CCP)

 

D

Data Integrity

Design History File (DHF)

Deviation

Device History Record (DHR)

Device Master Record (DMR)

Document Control

E

EU MDR: The European Medical Device Regulation

EUDAMED

Electronic Batch Records

Enterprise Quality Management Software (EQMS)

Environmental Management System (EMS)

Electronic Records

G

GAMP 5

GCP

GDP

GLP

GMP

GxP

I

In Vitro Diagnostics (IVD)

In Vitro Diagnostic Devices Regulation (IVDR)

ISO 13485 Standard

ISO 14971

L

Lean Six Sigma

Life Science

M

Medical Device

MEDDEV 2.12

MEDDEV 2.7 rev. 4

 

N

Nonconformity

P

PDCA Cycle

Pharma 4.0

Pharmaceutical Labeling

Product Requirements Document (PRD)

Premarket Approval (PMA)

Preventive Action

 

Q

Quality By Design (QbD)

Quality Control (QC)

Quality Culture

Quality Function Deployment (QFD)

Quality KPIs

Quality Management System (QMS)

Quality Management Process

Quality Management Software

Quality Risk Management

R

Risk Assessment

Risk Based Thinking

 

Risk Matrix

Root Cause Analysis

S

Six Sigma

Software as a Medical Device (SaMD)

T

Total Quality Management (TQM)

Training

V

Verification of Effectiveness (VoE) and Verification of Effectiveness Plan (VoEP)

Verification of Implementation (VoI)

W

Warning Letter

#

21 CFR Part 11 Compliance

510k

On this page you will find definitions of terms and concepts related to Quality Management in the Life Sciences Industry. 

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