Qualification and Validation (including 21 CFR Part 11)

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Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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0
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5,108
Marc
Discussions
lilybef
Number of lots required for stability testing of a Class II device in the 510(k)
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3
Views
74
lilybef
C
Karl Fischer Titrators and 21 CTR Part 11 and Paper Records
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6
Views
147
v9991
C
In cases where users of an electronic system change their names
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5
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161
v9991
C
ICP versus AA: How to determine appropriate specification for assay method verification
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1
Views
148
v9991
C
Signature manifestations - 21 CFR Part 11
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4
Views
247
chq
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
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7
Views
837
Sam Lazzara
P
Periodic Review - Deviations/incidents that are reviewed
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4
Views
260
v9991
I
GMP 21 CFR Part 11 Electronic Records Compliance Project Help
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9
Views
657
v9991
M
Who should have access to Audit trail?
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6
Views
259
v9991
S
FDA requirements and CAPA's
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2
Views
237
v9991
L
Understanding FDA requirements for Software Validation
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7
Views
8,471
v9991
I
Cleanroom Actions in case of Actions Limit Alarm
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2
Views
308
v9991
Sam Lazzara
Time Zero testing in med device aging studies
Replies
3
Views
415
v9991
R
FDA Requirements - Printing Equipment Software Validation
Replies
1
Views
230
yodon
Z
Does a website needs to comply with Part 11?
Replies
5
Views
159
yodon
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