Glossar

Hier finden Sie eine Erklärung der Fachbegriffe, welche ich in meinen Blogartikeln verwende:

A

    • AD: Active Directory
    • AGLP: Account – Globale Gruppe – Lokale Gruppe – Permission
    • ALCOA: Attributable, Legible, Contemporaneous, Original and Accurate
    • ALCOA+: Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring and Available
    • AMG: Arzneimittelgesetz
    • AMWHV: Arzneimittel- und Wirkstoffherstellungsverordnung

B

    • BPMN: Business Process Model and Notation

C

    • CAPA: Corrective and Preventive Action
    • cGMP: Current Good Manufacturing Practices
    • CPP: kritische Prozessparameter
    • CQA (CPA): kritische Qualitätsattribute
    • CSV: Computer-System-Validierung

D

    • DEP: Data Execution Prevention
    • DMS: Dokumenten-Management-System
    • DNS: Domain Naming Service
    • DS: Design Specification

E

    • EMA: European Medicines Agency

F

    • FAT32: File Allocation Table 32
    • FDA: Food and Drug Administration
    • FS: Functional Specification
    • FSMO: Flexible Single Master Object
    • FTP: File Transfer Protocol

G

    • GAMP: Good Automated Manufacturing Practice Supplier Guide
    • GUI: Graphical User Interface
    • GxP: Good Practice Guidelines

I

    • IDS: Intrusion Detection Systems
    • IMHO: In my humble opinin
    • IPS: Intrusion Prevention Systems
    • IQ: Installation Specification

L

    • LDAP: Lightweight Directory Access Protocol
    • LIMS: Laboratory Information Management System

M

    • MES: Manufacturing Execution Systems
    • MHRA: The Medicines and Healthcare products Regulatory Agency

N

    • NTFS: New Technology File System

O

    • OPC UA: Open Platform Communications Unified Architecture
    • OQ: Operational Specification

P

    • PIC/s: Pharmaceutical Inspection Co-operation Scheme
    • PQ: Performance Specification

Q

    • QA: Quality Assurance – Qualitätssicherung
    • QC: Quality Control – Qualitätskontrolle

R

    • Rolle: Gruppierung von Mitarbeitern, die die gleiche Aufgaben erfüllen

S

    • SIPOC-D: Supplier – Input – Process – Output – Customer – Data
    • SLA: Service-Level Agreement
    • SOP: Standard Operating Procedure
    • Systemkategorie: Gruppen von Systemen mit ähnlicher Konfiguration

T

U

    • URS: User Requirement Specification
    • USV / UPS: Unterbrechungsfreie Stromversorgung / Uninterruptible Power Supply

V

    • VUCA: Volatility, Uncertainty, Complexity, Ambiguity

W

    • WORM: Write Once Read Many