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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
     
    Change Control Software
     
    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
     
    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 210
     
    21 CFT Part 211
     
    21 CFR Part 11 Compliance
     
    510k
     
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