Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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0
Views
14K
Marc
Marc
Discussions
S
Ethylene oxide sterilization vendor change
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3
Views
252
v9991
V
imecoli
User Requirement Specifications (URS) questions
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4
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2K
JPhillips
J
C
Requirement traceability matrix
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7
Views
994
JPhillips
J
K
Process OQ for Swiss Turning Process
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2
Views
346
JPhillips
J
V
Printer - CSV /Data integrity/21 CFR part 11
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7
Views
412
v9991
V
S
Computer Software Validation
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3
Views
594
v9991
V
Castle
Revalidation intervals of the SIP for the WFI system
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1
Views
232
v9991
V
Castle
Temperature mapping EDLMs can be arranged with EDML locations every 20 or 30 metres.
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0
Views
171
Castle
Castle
D
Revalidation of production processes when a company purchase another company
Replies
7
Views
560
dee jay
D
Q
SharePoint - Can a page containing GMP docs be validated?
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7
Views
420
EmiliaBedelia
E
J
Dimensional program validations
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2
Views
595
Gambit 12
G
K
Calibrated Bubble Level for Qualification
2
Replies
13
Views
640
mattador78
M
M
OQ runs
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7
Views
464
Bev D
Bev D
M
Scope of validation for identical machines
Replies
8
Views
1K
BeeBoo
B
N
Machine design is still in 'Proof of Concept' stage
Replies
3
Views
335
nuraz
N
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