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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
5,716
Marc
Discussions
C
Looking for simple Software Validation IQ templates.
Replies
0
Views
30
CQUINT
Ed Panek
Part 11 Self Certify Memo
Replies
4
Views
130
Ed Panek
V
Calibration certificate verification
Replies
3
Views
90
ADSJT
H
Should I mention machine/Equipment password In SOP?
Replies
4
Views
114
Ninja
S
Computer System Validation of Bioinformatics Pipeline
Replies
3
Views
117
yodon
S
Validation of COTS Equipment plus Software
2
Replies
12
Views
402
yodon
D
ISO 13485 - Equipment validation , qualification
Replies
3
Views
182
yodon
Sam Lazzara
Lot Release Testing versus Process Validation Studies
Replies
9
Views
4,576
Stoic
A
How to do Equipment Validation - Establishing our ISO 13485 QMS procedures
2 3
Replies
26
Views
18,991
Marc
Q
Validation Guidance - Plastic Injection Molding Process
2 3
Replies
29
Views
42,518
iammstarr
A
System for Compliance Management (Medical Device)
Replies
4
Views
560
Andrea102
Ed Panek
Do Cloud services require 21 CFR Part 11 compliance?
Replies
7
Views
440
JJ_FDA
A
Validating my own application developed with Agile
Replies
5
Views
170
Andrea102
F
Organising IQ, OQ and PQ content in a "smart" way
Replies
3
Views
286
yodon
S
Do we need to validate Software used in Drug discovery and development process?
Replies
2
Views
219
JJ_FDA
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