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Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Replies
0
Views
8,935
Marc
Discussions
J
Validation Sample Size for Tray Seal
Replies
4
Views
748
MSterling
D
GAMP CAT 5 Change Control
Replies
9
Views
205
yodon
L
Validation without Tolerance
Replies
0
Views
80
LuniA19
W
Transport validation
Replies
4
Views
260
v9991
M
Is validation required when consumables are changed
Replies
6
Views
338
Tidge
I
What revalidation is necessary if we change parts in a WFI loop ?
Replies
1
Views
148
Thee Bouyyy
A
How to do Equipment Validation - Establishing our ISO 13485 QMS procedures
2 3 4
Replies
34
Views
23,628
chris1price
U
Validation of Wave Solder Process - PCBA for Medical Products
2
Replies
12
Views
6,724
Tidge
S
Medical device equipment calibration
Replies
1
Views
218
pziemlewicz
W
Transport validation
2
Replies
12
Views
576
v9991
S
How to perform verification of the Statistical Analysis Software?
Replies
7
Views
602
v9991
V
Periodic Audit Trail Review - Scope, Content & Frequency
2
Replies
11
Views
12,993
v9991
V
Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other )
Replies
0
Views
148
v9991
P
Cleaning Agents to be Used on Metals & Plastics
Replies
1
Views
152
prephil
I
Class VI certification on seals, o-ring and plastic for a WFI system
Replies
0
Views
107
ifserav
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