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1. 1. Glossary

Glossary

Learn terms in quality management and life sciences organized A–Z for quick reference.

A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

A

Adverse Event Reporting

Analytical Method Validation

Approval Workflow

Audit Readiness

Artificial Intelligence in Quality

Audit Management

B

Biocompatibility Testing

Biopharmaceutical Compliance

Business Continuity Management

C

CAPA (Corrective and Preventive Action)

Change Control Management

Calibration Management

Clinical Quality Assurance (CQA)

Complaint Handling

Computer System Validation (CSV)

Compliance Management

Customer Complaint Investigation

D

Device Master Record (DMR)

Device History Record (DHR)

Deviation Management

Document Control

Design Verification and Validation

E

Environmental Monitoring

Equipment Calibration

Electronic Batch Record (EBR)

Employee Competency Management

Escalation Workflow

Enterprise QMS Integration

F

Failure Mode and Effects Analysis (FMEA)

FDA 21 CFR Part 11 Compliance

Field Safety Corrective Action (FSCA)

First Article Inspection (FAI)

Functional Risk Assessment

Follow-up Corrective Action

G

Good Automated Manufacturing Practice (GAMP 5)

Good Clinical Practice (GCP)

Good Distribution Practice (GDP)

Good Documentation Practice (GDP)

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Global Regulatory Compliance

H

I

J

K

L

M

N

O

P

Q

R

S

T

U

V

W

X

Y

Z

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