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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
6,014
Marc
Discussions
C
Looking for simple Software Validation IQ templates.
Replies
4
Views
375
Adacus
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4
Replies
31
Views
43,322
zagwyn
A
We're currently looking for any studies performed on various PPE materials
Replies
1
Views
96
Jim Wynne
F
Bayes Success run Theorem for sample size during OQ&PQ
Replies
3
Views
106
Florent73
B
What is 'equipment'?
Replies
2
Views
140
yodon
Ed Panek
Part 11 Self Certify Memo - What else should it cover?
Replies
5
Views
320
MC Eistee
V
Calibration certificate verification
Replies
3
Views
196
ADSJT
H
Should I mention machine/Equipment password In SOP?
Replies
4
Views
201
Ninja
S
Computer System Validation of Bioinformatics Pipeline
Replies
3
Views
200
yodon
S
Validation of COTS Equipment plus Software
2
Replies
12
Views
563
yodon
D
ISO 13485 - Equipment validation , qualification
Replies
3
Views
301
yodon
Sam Lazzara
Lot Release Testing versus Process Validation Studies
Replies
9
Views
4,998
Stoic
A
How to do Equipment Validation - Establishing our ISO 13485 QMS procedures
2 3
Replies
26
Views
19,349
Marc
A
System for Compliance Management (Medical Device)
Replies
4
Views
597
Andrea102
Ed Panek
Do Cloud services require 21 CFR Part 11 compliance?
Replies
7
Views
589
JJ_FDA
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