Glossary

0-9

21 CFR Part 11
6σ

A

Anvisa
APR

B

Batch
Batch Record

D

Data Matrix code
Delegated Regulation 2016/161/EU
Directive 2011/62/EU

E

EBR
EMA
ERP

F

FAT
FDA
FDS

G

GAMP® 5
GMP
GS1
GTIN

I

Industry 4.0
ISA-88
ISA-95

L

LiSI

M

MES

O

OEE

P

Production Management

R

RbE
RFID
RTM

S

S-TTS
SAT

T

The Connected Enterprise

U

URS

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