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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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Part 11 Hybrid System - Partial paper based record but with e-signature
Phatkid
Oct 19, 2010
Replies
4
Views
3,862
Oct 22, 2010
Phatkid
J
Critical Process Parameters vs. Critical Performance Parameters - Definitions
jars4u
Oct 2, 2010
Replies
2
Views
6,361
Oct 2, 2010
v9991
Validation of SAP - Secondary Packaging Manufacturer
ScottK
Sep 15, 2010
Replies
8
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3,692
Sep 27, 2010
JaxQC
F
Aged Inspection Equipment Software has no Audit Trail - Validation of Software
Frank Haberbosch
Sep 23, 2010
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2,939
Sep 27, 2010
Jerome
S
Understanding of Process Validations - ISO 9001 Clause 7.5.2 Validation
SarahSD
Sep 8, 2010
Replies
9
Views
7,094
Sep 20, 2010
blueboat
J
Shelf Life Validation for new Heat Impulse Medical Packaging Sealer
JJLit
Sep 8, 2010
Replies
2
Views
3,772
Sep 9, 2010
bio_subbu
M
GLP (Good Laboratory Practices) Requirement for Sterility Validations
MarkinCalifornia
Sep 3, 2010
Replies
1
Views
4,394
Sep 3, 2010
Sam Lazzara
R
Software & 21 CFR Part 11 Back Toward Center Stage
RussKing3
Aug 29, 2010
Replies
1
Views
2,008
Aug 30, 2010
Stijloor
Q
Medical Device Field Service Performance Inspection Process Validation
QE
Aug 26, 2010
Replies
1
Views
3,071
Aug 26, 2010
MIREGMGR
L
Validation and documentation activities required for a custom-made software
leohillman
Aug 23, 2010
Replies
2
Views
2,713
Aug 24, 2010
RussKing3
T
Development of IOQ Protocols - Validation in the Pharmaceutical Industry
Twigs85
Apr 17, 2007
Replies
3
Views
16,662
Aug 17, 2010
harry
W
Oven Leak Test Method - Integrity of the chamber to hold gas
wes77
Aug 13, 2010
Replies
3
Views
2,891
Aug 13, 2010
tomvehoski
W
Is an Oven I/O/Q Validation Required or is Calibration Sufficient?
wes77
Aug 9, 2010
Replies
7
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4,961
Aug 11, 2010
BradM
K
Cleaning Validation Plans, Sampling, etc - Allergens in Food
kees tilburg
Aug 11, 2010
Replies
1
Views
3,180
Aug 11, 2010
Stijloor
C
Validation of OTS (Off-the-Shelf) Training Software - Necessary?
Calico
Aug 3, 2010
2
Replies
13
Views
5,474
Aug 9, 2010
Calico
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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