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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
6,195
Marc
Discussions
Z
Qualification of AzureDevOps in Gxp
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0
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28
zippo
P
Periodic Review - Deviations/incidents that are reviewed
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5
Views
861
v9991
D
ISO 13485 - Equipment validation , qualification
Replies
6
Views
429
Frypot
C
Looking for simple Software Validation IQ templates.
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4
Views
482
Adacus
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4
Replies
31
Views
43,782
zagwyn
A
We're currently looking for any studies performed on various PPE materials
Replies
1
Views
157
Jim Wynne
F
Bayes Success run Theorem for sample size during OQ&PQ
Replies
3
Views
193
Florent73
B
What is 'equipment'?
Replies
2
Views
194
yodon
Ed Panek
Part 11 Self Certify Memo - What else should it cover?
Replies
5
Views
376
MC Eistee
V
Calibration certificate verification
Replies
3
Views
223
ADSJT
H
Should I mention machine/Equipment password In SOP?
Replies
4
Views
225
Ninja
S
Computer System Validation of Bioinformatics Pipeline
Replies
3
Views
239
yodon
S
Validation of COTS Equipment plus Software
2
Replies
12
Views
618
yodon
Sam Lazzara
Lot Release Testing versus Process Validation Studies
Replies
9
Views
5,070
Stoic
A
How to do Equipment Validation - Establishing our ISO 13485 QMS procedures
2 3
Replies
26
Views
19,528
Marc
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