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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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Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
Views
12K
Oct 18, 2009
Marc
Discussions
M
Instrument Qualification
Milas
Friday at 10:05 AM
Replies
2
Views
83
Yesterday at 9:28 AM
v9991
V
M
Scope of validation for identical machines
MayaLe
Mar 13, 2024
Replies
3
Views
187
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
Views
705
Apr 8, 2024
v9991
V
V
Criteria for categorisation of GAMP 3 and GAMP 5 of standalone systems
v9991
Apr 7, 2024
Replies
0
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51
Apr 7, 2024
v9991
V
B
Equipment Validation
bguarino
Apr 5, 2024
Replies
1
Views
90
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
Views
435
Apr 7, 2024
v9991
V
M
Component Qualification
Milas
Mar 29, 2024
Replies
6
Views
179
Mar 29, 2024
Bev D
Complying with 21 CFR 11
Quality_Goblin
Feb 22, 2024
Replies
7
Views
429
Mar 14, 2024
Ed Panek
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Lab Water Systems Verification and Validation
JoJoPinko
Feb 15, 2024
Replies
0
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212
Feb 15, 2024
JoJoPinko
J
A
Cleaning Validation
Abake
Feb 9, 2024
Replies
1
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232
Feb 12, 2024
planB
H
Commercializing/destruction Class IIa Invasive devices Post-Transport Testing
hassa122
Jan 9, 2024
Replies
0
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310
Jan 9, 2024
hassa122
H
M
Test Method Validation of Vision System
msk92
Dec 14, 2023
Replies
2
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687
Jan 2, 2024
msk92
M
D
Validating Operating system
diogo19
Aug 11, 2021
Replies
7
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2K
Oct 13, 2023
Tidge
T
User Requirement Specifications (URS) questions
imecoli
Sep 21, 2023
Replies
2
Views
633
Oct 2, 2023
imecoli
OQ on a Heat Sealer
bettsaj
Sep 18, 2023
Replies
2
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532
Sep 19, 2023
chris1price
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