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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
6,531
Marc
Discussions
S
Validation Records - Very young QMS
Replies
2
Views
167
yodon
D
Performance of high shear mixer (or rapid mixing granulator
Replies
4
Views
147
Duyen
S
Computer System Validation of Bioinformatics Pipeline
Replies
5
Views
350
yodon
Z
Qualification of AzureDevOps in Gxp
2
Replies
12
Views
511
sreekiran14
F
Bayes Success run Theorem for sample size during OQ&PQ
Replies
4
Views
427
Aaron M
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4
Replies
32
Views
44,737
zagwyn
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
2
Replies
12
Views
3,853
v9991
P
Periodic Review - Deviations/incidents that are reviewed
Replies
5
Views
1,010
v9991
D
ISO 13485 - Equipment validation , qualification
Replies
6
Views
605
Frypot
C
Looking for simple Software Validation IQ templates.
Replies
4
Views
711
Adacus
A
We're currently looking for any studies performed on various PPE materials
Replies
1
Views
300
Jim Wynne
B
What is 'equipment'?
Replies
2
Views
240
yodon
Ed Panek
Part 11 Self Certify Memo - What else should it cover?
Replies
5
Views
436
MC Eistee
V
Calibration certificate verification
Replies
3
Views
295
ADSJT
H
Should I mention machine/Equipment password In SOP?
Replies
4
Views
272
Ninja
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