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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.
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    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

     

    Annex 11

     

    APQR

     

    ATMP

     

    Audit Trail

     

    C

    CAPAs

     

    cGMP

     

    Change Control

     

    Clinical Data Management (CDM)

     

    Clinical Trial

     

    Compliance

     

    Computer System Validation (CSV)

     

    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

    IEC 62304

     

    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

     

    ISO 9001:2015

     

    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 quality system (PQS)

     

    Pharmaceutical Labeling

     

    Product Requirements Document (PRD)

     

    Premarket Approval (PMA)

     

    Preventive Action

     

    Q

    Quality 4.0

     

    Quality Assurance

     

    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

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    #

    21 CFR Part 11 Compliance

     

    510k

     
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