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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
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0
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5,202
Marc
Discussions
D
Software Validation - Contract manufacturer of Components (PCBA's)
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2
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66
dbaz
V
  • Poll
Open vs Closed Systems - Criteria for Categorization in cGMP Environment
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4
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7,656
melancholy
V
Periodic Audit Trail Review - Scope, Content & Frequency
2
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10
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5,275
melancholy
G
Correction fluid found on documents that are reviewed
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8
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153
Marc
I
HEPA Filter Integrity test ISO class 9 room
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2
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78
Chaitany Thaker
Z
Security for Approvals - Cloud based Complaint, NC, and CAPA systems
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8
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110
Ronen E
J
Welding Process Validation Plan
2
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18
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11,231
AgnieszkaSz
A
System for Compliance Management (Medical Device)
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4
Views
228
Andrea102
C
In cases where users of an electronic system change their names
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6
Views
255
rogerpenna
Z
Class 2 medical device - Process Validation - Test sterile or non-sterile units?
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4
Views
199
yodon
lilybef
Number of lots required for stability testing of a Class II device in the 510(k)
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3
Views
205
lilybef
C
Karl Fischer Titrators and 21 CTR Part 11 and Paper Records
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6
Views
214
v9991
C
ICP versus AA: How to determine appropriate specification for assay method verification
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1
Views
208
v9991
C
Signature manifestations - 21 CFR Part 11
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4
Views
339
chq
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
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7
Views
1,159
Sam Lazzara
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