QMS (Qualitätsmanagementsystem)

QSR 21 CFR 820.1 Scope
QSR 21 CFR 820.3 Definitions
QSR 21 CFR 820 5 Quality System

DOCU (Dokumentenkontrolle)

QSR 21 CFR 820.30(i) Design Changes
(with ENGR)
QSR 21 CFR 820.40 Document Controls
QSR 21 CFR 820.70(b) Prod/Process
Changes (with PROD)
QSR 21 CFR 820.180 Records
QSR 21 CFR 820.186 Quality System Record

ENGR (Entwicklung)

QSR 21 CFR 820.30 Design Controls 
(with DOCU)
QSR 21 CFR 820.60 Product Ident.
(with PROD, PURC & QUAL)
QSR 21 CFR 820.65 Traceability (Lot/SN)
(with PROD, PURC & QUAL)
QSR 21 CFR 820.70(a) Prod. Specifications
QSR 21 CFR 820.120(a) Label Design
QSR 21 CFR 820.130 Packaging Design

FAMA (Infrastruktur)

QSR 21 CFR 820.70(c) Environmental Controls
(with PROD)
QSR 21 CFR 820.70(f) Buildings

HR (Personalwesen)

QSR 21 CFR 820.25 Personnel
QSR 21 CFR 820.70(d) Personnel training 
(with PROD)

IT (Informationstechnologien)

QSR 21 CFR 820.70(i) IT Maintenance 

MGMT (Management)

QSR 21 CFR 820.20 Mgmt Responsibility
QSR 21 CFR 820.22 Effectiveness (with QUAL)
QSR 21 CFR 820.250 Statistical Techniques

PROD (Produktion)

QSR 21 CFR 820.60 Product Identification 
(with ENGR, PURC & QUAL)
QSR 21 CFR 820.65 Product Traceability
(with ENGR, PURC & QUAL)
QSR 21 CFR 820.70 Prod./Process Control
(Not (f), Builldings: See FAMA)
QSR 21 CFR 820.75 Process Validation
QSR 21 CFR 820.120 Device Labeling 
QSR 21 CFR 820.140 Handling
QSR 21 CFR 820.150 Storage
QSR 21 CFR 820.160 Distribution (process)
QSR 21 CFR 820.170 Installation 
QSR 21 CFR 820.184 DHR
QSR 21 CFR 820.198 Complaints
QSR 21 CFR 820.200 Servicing

PURC (Einkauf) 

QSR 21 CFR 820.50 Purchasing Control
(with QUAL)
QSR 21 CFR 820.60 Product Identification
(with ENGR, PROD & QUAL)
QSR 21 CFR 820.65 Traceability
(with ENGR, PROD & QUAL)

QUAL (Qualitätssicherung / Qualitätskontrolle)

QSR 21 CFR 820.22 Quality Audit (with MGMT)
QSR 21 CFR 820.50 Purchasing Controls
(SCARs - with PURC)
QSR 21 CFR 820.60 Product Identification
(with ENGR, PROD & PURC)
QSR 21 CFR 820.65 Product Traceability
(with ENGR, PROD & PURC)
QSR 21 CFR 820.70(g) Equip Inspection & Maintenance 
(with PROD)
QSR 21 CFR 820.72 Inspection & Testing
QSR 21 CFR 820.80 Inspection
QSR 21 CFR 820.86 Acceptance Status
QSR 21 CFR 820.90 Nonconforming Product
QSR 21 CFR 820.100 CAPA
QSR 21 CFR 820.120b Label Inspection 
QSR 21 CFR 820.160 Distribution (QC of records)

REGU (gesetzliche Anforderungen)

FDA 21 CFR 800-1299 Including 801,803,
806, 812, 814, 821, 822, 830, 860 & 861
QSR 21 CFR 820.181 DMR

SAMA (Vertrieb & Marketing)

QSR 21 CFR 820.160 Distribution
(with PROD)