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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Qualification and Validation (including 21 CFR Part 11)
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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0
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5,108
Oct 18, 2009
Marc
Discussions
Number of lots required for stability testing of a Class II device in the 510(k)
lilybef
Feb 7, 2019
Replies
3
Views
74
Feb 11, 2019
lilybef
C
Karl Fischer Titrators and 21 CTR Part 11 and Paper Records
ChemistAnalytical
Jan 9, 2019
Replies
6
Views
147
Jan 15, 2019
v9991
C
In cases where users of an electronic system change their names
chq
Jan 14, 2019
Replies
5
Views
161
Jan 15, 2019
v9991
C
ICP versus AA: How to determine appropriate specification for assay method verification
ChemistAnalytical
Jan 7, 2019
Replies
1
Views
148
Jan 14, 2019
v9991
C
Signature manifestations - 21 CFR Part 11
chq
Nov 26, 2018
Replies
4
Views
247
Jan 4, 2019
chq
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
Mark Meer
Aug 27, 2018
Replies
7
Views
837
Jan 1, 2019
Sam Lazzara
P
Periodic Review - Deviations/incidents that are reviewed
PGD
Oct 23, 2018
Replies
4
Views
260
Jan 1, 2019
v9991
I
GMP 21 CFR Part 11 Electronic Records Compliance Project Help
iimp24ii
Sep 19, 2018
Replies
9
Views
657
Jan 1, 2019
v9991
M
Who should have access to Audit trail?
micheliAL
Oct 19, 2018
Replies
6
Views
259
Jan 1, 2019
v9991
S
FDA requirements and CAPA's
smicklo
Oct 16, 2018
Replies
2
Views
237
Jan 1, 2019
v9991
L
Understanding FDA requirements for Software Validation
LiamD
Aug 18, 2008
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7
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8,471
Jan 1, 2019
v9991
I
Cleanroom Actions in case of Actions Limit Alarm
ifserav
Sep 6, 2018
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2
Views
308
Jan 1, 2019
v9991
Time Zero testing in med device aging studies
Sam Lazzara
Aug 23, 2018
Replies
3
Views
415
Jan 1, 2019
v9991
R
FDA Requirements - Printing Equipment Software Validation
rfoley14411
Nov 15, 2018
Replies
1
Views
230
Nov 28, 2018
yodon
Z
Does a website needs to comply with Part 11?
ZEE9995
Nov 20, 2018
Replies
5
Views
159
Nov 20, 2018
yodon
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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