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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Qualification and Validation (including 21 CFR Part 11)
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
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13K
Oct 18, 2009
Marc
Discussions
D
Wooden pallet in storage areas according to GMP
deborasdfs
Yesterday at 11:05 AM
Replies
0
Views
33
Yesterday at 11:05 AM
deborasdfs
D
OQ on a Heat Sealer
bettsaj
Sep 18, 2023
Replies
4
Views
653
Apr 27, 2024
humoor
A
Cleaning Validation
Abake
Feb 9, 2024
Replies
2
Views
308
Apr 25, 2024
v9991
V
User Requirement Specifications (URS) questions
imecoli
Sep 21, 2023
Replies
3
Views
694
Apr 24, 2024
v9991
V
J
Lab Water Systems Verification and Validation
JoJoPinko
Feb 15, 2024
Replies
1
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302
Apr 22, 2024
v9991
V
V
Criteria for categorisation of GAMP 3 and GAMP 5 of standalone systems
v9991
Apr 7, 2024
Replies
3
Views
141
Apr 17, 2024
Tidge
T
D
Validating Operating system
diogo19
Aug 11, 2021
Replies
8
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2K
Apr 16, 2024
v9991
V
M
Instrument Qualification
Milas
Apr 12, 2024
Replies
2
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151
Apr 15, 2024
v9991
V
M
Scope of validation for identical machines
MayaLe
Mar 13, 2024
Replies
3
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235
Apr 8, 2024
v9991
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V
PQ parameters for computer system validation of configurable software of laboratory equipment
v9991
May 10, 2023
Replies
1
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757
Apr 8, 2024
v9991
V
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Equipment Validation
bguarino
Apr 5, 2024
Replies
1
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151
Apr 7, 2024
v9991
V
10 identical machines, can I conduct IOQ in one machine and do verification only to the remaining ones?
Javier Guan
Mar 7, 2024
Replies
6
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493
Apr 7, 2024
v9991
V
M
Component Qualification
Milas
Mar 29, 2024
Replies
6
Views
234
Mar 29, 2024
Bev D
Complying with 21 CFR 11
Quality_Goblin
Feb 22, 2024
Replies
7
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513
Mar 14, 2024
Ed Panek
H
Commercializing/destruction Class IIa Invasive devices Post-Transport Testing
hassa122
Jan 9, 2024
Replies
0
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328
Jan 9, 2024
hassa122
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