Glossar
- 21CFR11 = Code of Federal Regulations Title 21 Part 11 (Computerised Systems)
- Annex11 = European Commission, Annex 11, (Computerised Systems)
- CES = Comité Électrotechnique Suisse (SEV)
- CSV = Computerised Systems Validation
- DS = Design Specification
- EBR = Electronic Batch Record
- ENEC = European Norms Electrical Certification
- ERP = Enterprise Resource Planning
- FDA = Food and Drug Administration
- FS = Functional Specification
- GAMP = Good Automation Manufacturing Practice
- GXP = Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
- MBR = Master Batch Record
- MES = Manufacturing Execution System
- IQ = Installation Qualification
- OEM = Original Equipment Manufacturer
- OQ = Operational Qualification
- PQ = Performance Qualification
- SOP = Standard Operating Procedure
- UAT = User Acceptance Test
- UL = Underwriters Laboratories
- URS = User Requirement Specification