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Glossary

On this page, you will find definitions of terms and concepts related to Quality Management in the Life Sciences Industry.
Illustration that represents a glossary of quality-related terms | Scilife

A C D E F G I L M N O P Q R S T V W #

A

ALCOA

 

APQR

 

ATMP

 

Audit Trail

 

C

CAPAs

 

cGMP

 

Change Control

 

Clinical Data Management (CDM)

 

Clinical Trial

 

Compliance

 

Continuous Improvement

 

Corrective action

 

Cost of Quality (CoQ)

 

Cost of Poor Quality

 

Critical Control Point (CCP)

 

D

Data Integrity

 

Design Control | Video

 

Design History File (DHF)

 

Design Inputs

 

Design Transfer

 

Deviation

 

Device History Record (DHR)

 

Device Master Record (DMR)

 

Document Control

 

E

EU MDR: The European Medical Device Regulation

 

EUDAMED

 

Electronic Batch Records

 

Electronic Signature

 

Enterprise Quality Management Software (EQMS)

 

Environmental Management System (EMS)

 

Electronic Records

 

F

Form 483

 

G

GAMP 5

 

GCP

 

GDocP

 

GDP

 

GLP

 

GMP

 

GxP

 

I

Installation Qualification (IQ)

 

International Council for Harmonization (ICH)

 

Internet of Medical Things (IoMT)

 

In Vitro Diagnostics (IVD)

 

In Vitro Diagnostic Devices Regulation (IVDR)

 

ISO 13485 Standard

 

ISO 14971

 

ISO 15189

 

ISO 17025

 

L

Lean Six Sigma

 

Life Science

 

M

Medical Device

 

MEDDEV 2.12

 

MEDDEV 2.7 rev

 

N

New Drug Application (NDA)

 

New Product Introduction (NPI)

 

Nonconformity

 

O

Operational Qualification (OQ)

 

Out of Expectation (OOE)

 

Out-of-Specification (OOS)

 

Out of trend (OOT)

 

P

PDCA Cycle

 

Performance Qualification

 

Performance Qualification Protocol

 

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 Maturity

 

Quality Management System (QMS)

 

Quality Management Process

 

Quality Management Software

 

Quality Risk Management

 

R

Risk Assessment

 

Risk Based Thinking

 

Risk Matrix

 

Root Cause Analysis

 

Root Cause Investigation (RCI)

 

S

Six Sigma

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Software as a Medical Device (SaMD)

Read More  

T

Total Quality Management (TQM)

 

Training

 

V

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

 

Verification of Implementation (VoI)

 

W

Warning Letter

Read More  

#

21 CFR Part 11 Compliance

 

510k

 
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