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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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FAQs
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
Views
12K
Oct 18, 2009
Marc
Discussions
10 identical machines, can I conduct IOQ in one machine and do verification only to the remaining ones?
Javier Guan
Mar 7, 2024
Replies
5
Views
365
Mar 19, 2024
Javier Guan
Complying with 21 CFR 11
Quality_Goblin
Feb 22, 2024
Replies
7
Views
344
Mar 14, 2024
Ed Panek
M
Scope of validation for identical machines
MayaLe
Mar 13, 2024
Replies
2
Views
109
Mar 14, 2024
chris1price
J
Lab Water Systems Verification and Validation
JoJoPinko
Feb 15, 2024
Replies
0
Views
172
Feb 15, 2024
JoJoPinko
J
A
Cleaning Validation
Abake
Feb 9, 2024
Replies
1
Views
197
Feb 12, 2024
planB
H
Commercializing/destruction Class IIa Invasive devices Post-Transport Testing
hassa122
Jan 9, 2024
Replies
0
Views
282
Jan 9, 2024
hassa122
H
M
Test Method Validation of Vision System
msk92
Dec 14, 2023
Replies
2
Views
649
Jan 2, 2024
msk92
M
D
Validating Operating system
diogo19
Aug 11, 2021
Replies
7
Views
2K
Oct 13, 2023
Tidge
T
User Requirement Specifications (URS) questions
imecoli
Sep 21, 2023
Replies
2
Views
594
Oct 2, 2023
imecoli
OQ on a Heat Sealer
bettsaj
Sep 18, 2023
Replies
2
Views
505
Sep 19, 2023
chris1price
E
Worst-case Sealing device selection
erdal88
Jul 6, 2023
Replies
2
Views
695
Jul 7, 2023
erdal88
E
D
Screenshots as evidence ?
diogo19
Jun 16, 2023
Replies
4
Views
950
Jun 16, 2023
yodon
Y
R
SAP B1 Computer System Validation
Ranzeeth
Sep 23, 2021
Replies
2
Views
1K
May 11, 2023
yodon
Y
V
PQ parameters for computer system validation of configurable software of laboratory equipment
v9991
May 10, 2023
Replies
0
Views
650
May 10, 2023
v9991
V
D
Supplier Qualification
donna0816
Apr 25, 2023
Replies
2
Views
786
Apr 25, 2023
yodon
Y
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Food and Drug (Pharmaceuticals) related Regulations
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