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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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I
PLC (Programmable Logic Controller) Qualification Requirements
ifserav
Sep 21, 2011
2
Replies
11
Views
5,714
Dec 9, 2011
JaxQC
K
ISO 15189, QA & how to calibration for Balance, refrigerator and centrifuge?
Kelukelu
Nov 21, 2011
Replies
5
Views
8,789
Dec 6, 2011
Kelukelu
Q
IQ / OQ and PQ Project template wanted
QE
Mar 3, 2010
2
Replies
12
Views
16,981
Oct 14, 2011
Mohammed Gouda
A
Does the V&V (Verification and Validation) belong to Bench Testing for 510k?
asadr
Sep 16, 2011
Replies
2
Views
2,784
Sep 19, 2011
Ronen E
V
21 CFR Part 11 Electronic Data Storage Requirements vs. Paper Records
v9991
Aug 26, 2011
Replies
2
Views
3,584
Aug 30, 2011
BradM
W
Validation of SAP for ERP - Inventory, shipping, and monitoring expiration dates
wes77
Jan 19, 2010
2
Replies
18
Views
9,936
Aug 23, 2011
nine11c2
L
Compliance to 21 CFR Part 11 - Where to start??
lynxbct
Dec 22, 2009
2
3
Replies
20
Views
7,898
Aug 10, 2011
sueliu - 2012
A
Sample Size for Design Verification (Prototype Testing) for Medical Devices
amadeuscurse
Nov 17, 2010
2
Replies
12
Views
21,344
Jul 27, 2011
ctct61t
J
User Requirement Specification (URS) for off the shelf software
janwe
Jan 8, 2008
Replies
7
Views
8,121
Jul 5, 2011
dwebb
S
Is PQ and Performance Verification the same?
superkidz
Jun 18, 2011
Replies
1
Views
2,646
Jun 19, 2011
Ajit Basrur
I
Permanence Time Study during a Validation
ifserav
May 30, 2011
Replies
4
Views
2,446
Jun 3, 2011
The Specialist
S
Which Normality Test more acceptable to FDA; Also, Non-Normal Threshold?
snakepitt
May 23, 2011
Replies
5
Views
3,677
May 24, 2011
snakepitt
T
Medical Device Manufacturer Document Control Computer System Validation
Tarrah
Mar 4, 2011
Replies
4
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3,151
Apr 27, 2011
sagai
B
Autoclave Revalidation Methods
Brotri
Apr 7, 2011
Replies
5
Views
4,127
Apr 15, 2011
Brotri
D
Verification Requirements in a Machining Process
D Starr
Mar 8, 2011
Replies
6
Views
2,517
Apr 6, 2011
RogerG
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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