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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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Operational Qualification for injection molding process
sebastian12
Oct 11, 2009
Replies
2
Views
7,454
Oct 14, 2009
Juan Dude
E
Equipment Qualification - IQ, OQ and PQ
evilchilli_420
Oct 1, 2009
Replies
2
Views
6,010
Oct 1, 2009
Ajit Basrur
S
Retrospective Validation of Injection Moulded Class I Medical Devices
seank
Sep 23, 2009
Replies
2
Views
2,942
Sep 24, 2009
jscholen
R
How much Training for Process Validation? Process Performance Qualifications
rebecca.hess
Sep 23, 2009
Replies
5
Views
2,081
Sep 24, 2009
Denis
G
IQ, OQ, PQ Package for Label Printer Applicator and Software Validation - Help wanted
gar4guv
Sep 15, 2009
Replies
2
Views
11,139
Sep 22, 2009
Juan Dude
F
Conversion from Agile - Need cheaper FDA compliant software
foxr01 - 2009
Sep 14, 2009
Replies
7
Views
3,064
Sep 14, 2009
Jim Ivey
Sections 7.3.5 and 7.3.6 Verification and validation ownership
amjadrana
Sep 11, 2009
Replies
2
Views
1,946
Sep 11, 2009
gholland
J
Clause 7.5.2 applicability to a CRO (Clinical Research Organisation)
jaykashkap - 2009
Jul 22, 2009
Replies
3
Views
1,968
Sep 5, 2009
harry
S
Master Validation Plan - What must be included in a "Master Validation Plan"?
SK Vision
Jul 31, 2009
Replies
5
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6,808
Sep 3, 2009
Juan Dude
C
Software Validation Procedure per FDA requirement
Cinti
Aug 31, 2009
Replies
3
Views
4,648
Sep 3, 2009
alex.Kennedy
A
Validation of an Excel Spreadsheet used for Recording Test Results
achorste
Aug 10, 2009
2
Replies
14
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7,330
Aug 17, 2009
achorste
N
Software Requirements specification vs. Design Specification - Differences
NathaliaM
Mar 25, 2009
2
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10
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23,792
Aug 12, 2009
Dindo
K
EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation
karthic
Aug 9, 2009
Replies
5
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8,337
Aug 10, 2009
Ajit Basrur
P
Requirements for software providers for the medical device field
Penguin
Jul 22, 2009
Replies
5
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2,106
Aug 6, 2009
alex.Kennedy
R
Process Validation Issues - Active Pharmaceutical Ingredients
reddys
Aug 2, 2009
Replies
2
Views
2,722
Aug 3, 2009
raghu_1968
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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