Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Replies
0
Views
7,511
Marc
Discussions
D
Test Method Validation
Replies
4
Views
194
William55401
M
How to validate hundreds or even thousands of parts?
Replies
7
Views
2,060
Stoic
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4
Replies
39
Views
47,673
Mostafa Yousef
V
Process, component or full product re-qualification: leaded to unleaded solder
Replies
8
Views
483
msbettyhunt
B
IQ/OQ/PQ of CNC Milling Machine
Replies
3
Views
390
John Broomfield
M
Is Validation of Plating Processes required and who is responsible?
2
Replies
11
Views
833
duinyk
Z
Does a website needs to comply with Part 11?
Replies
6
Views
593
thecsvexpert2020
S
Heat Sealers Upper and lower limit setting during OQ for Heat Sealer
Replies
0
Views
225
Silvia tiozzo
D
DQ documents of new equipment - Function specification
Replies
0
Views
363
Duyen
S
Rees System Validation
Replies
1
Views
317
Ajit Basrur
D
CSV - Periodic Review
Replies
1
Views
339
yodon
I
Cleanroom Actions in case of Actions Limit Alarm
Replies
3
Views
1,017
Dasha
S
Validation Records - Very young QMS
Replies
2
Views
594
yodon
D
Performance of high shear mixer (or rapid mixing granulator
Replies
4
Views
474
Duyen
S
Computer System Validation of Bioinformatics Pipeline
Replies
5
Views
766
yodon
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