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Glossary / Acronyms

AcronymMeaning
2016/161/EUEU Directive on Falsified Medicines
2DTwo-dimensional
Six Sigma
AAAAsian Anti-Counterfeit Association
ABPIAssociation of British Pharmaceutical Industries
AIApplication Identifier
AIDCAutomatic Identification and Data Capture
ANVISAThe National Agency of Sanitary Surveillance in Brazil
APIActive Pharmaceitical Industries
APRAnnual Product Review
APSAdvanced Planning and Scheduling
BPCBulk Pharmaceutical Chemicals
CAPACorrective And Preventive Action
CDRHCenter for Device Evaluation and Radiological Health
CENEuropean Committee for Standardization
CFDAChina Food and Drug Administration
CFRCode of Federal Regulations
CFR 21 part 11CFR Titel 21 part 11 Electronic records, electronic signatures
CGMPCurrent Good Manufacturing Practice
CIPCleaning in Place
CISClinical Information System
CMOContract Manufacturing Organization
CoCChain of Custody
CoOChain of Ownership
COPCleaning off place
CPSICanadian Patient Safety Institute
CRChange Request
CROContract (Clinical) Research Organisation
CSVComputer System Validation
DCSDistributed Control System
DIPDrying in Place
DMCData Matrix Code
DSCSADrug Supply Chain Security Act
EBRElectronic Batch Record
EDIElectronic Data Interchange
EDLEssential Drug List
EFPIAEurop. Federation of Pharmaceutical Industries & Associations
EHRElectronic Health Record
EMAEuropean Medicines Agency
eMARelectronic Medicine Administration Record
EMVOEuropean Medicines Verification Organisation
EMVSEuropean Medicines Verification System
EPCElectronic Product Code
EPCISElectronic Product Code Information Services
ePedigreeElectronic Pedigree
ERPEnterprise Resource Planning
FATFactory Acceptance Test
FDAFood and Drug Administration
FDSFunctional Design Specification
FMDFalsified Medicines Directive
FSDFunctional Specifications Document
GAMPGood Automated Manufacturing Practice
GCPGood Clinical Practice
GDSNGlobal Data Synchronization Network
GDTIGlobal Document Type Identifier
GIAIGlobal Individual Asset Identifier
GLNGlobal Location Number
GLPGood Laboratory Practice
GMDNGlobal Medical Device Nomenclature
GMPGood Manufacturing Practice
GS1Organization that develops and maintains widely used codes
GSMGlobal Standard Management Process
GSRNGlobal Service Relationship Number
GTINGlobal Trade Item Number
GTSHGlobal Traceability Standard for Healthcare
HDMAHealthcare Distribution Management Association
HITHealthcare Information Technology
HMIHuman Machine Interface
IACCInternational Anti-Counterfeiting Coalition
ICCBBAInternational Council for Commonality in Blood Banking Automation, Inc.
IECInternational Electronical Commission
IHTSDOInternational Health Terminology Standards Development Organization
IMDRFInternational Medical Device Regulators Forum (formerly named GHTF)
IPCIn Process Control
ISAInternational Society of Automation
ISOInternational Standards Organization
ISPEInternational Society for Pharmaceuticals Engineering
KPIKey Performance Indicator
MAHMarketing Authorization Holder
MBRMaster Batch Record
MESManufacturing Execution System
MRPManufacturing Resource Planning
NCePNetwork Centric ePedigree
NDANew Drug Application
NHRNNational Healthcare Reimbursement Number
NMVONational Medicines Verification Organization
NTINNational Trade Item Number
NVSNational Verification System
OBPOnboarding Partner
OCROptical Character Recognition
OCVOptical Character Verification
OEEOverall Equipment Effectiveness
OEMOriginal Equipment Manufacturers
ONSObject Name Service
OPEOverall Process Effectiveness
OTCOver-The-Counter
PATProcess Analytical Technology
PCSProcess Control System
PIAProduct Identifier Authentication
PLMProduct Lifecycle Management
PQRProduct Quality Review
PRMProduct Requirements Documents
QAQuality Assurance
QFDQuality Function Deployment
QPQualified Person
RbEReview by Exception
RFCRemote Function Call
RFIDRadio Frequency Identification
ROIReturn on Investment
RTMRequirement Traceability Matrix
Rx DrugsPrescription Drugs
SATSite Acceptance Test
SCADASupervisory Control and Data Acquisition
SCMSupply Chain Management
SDSSoftware Design Specification
SFCSequential Function Chart
SLAService Level Agreement
SOPStandard Operating Procedure
SPCStatistical Process Control
SRINService Relation Instance Number
SSCCSerial Shipping Container Code
TCOTotal Cost of Ownership
TDSTag Data Standard
TPMTotal Productive Maintenance
TQCTotal Quality Control
TQMTotal Quality Management
TraxeedSerialization Solutions from Level 1 to Level 5
UCUnit Cost
UDIUnique Device Identification
UDIDUnique Device Identification Database
URSUser Requirement Specification
WHOWorld Health Organization
WIPWork in Process
WRWork Request