Qualification and Validation (including 21 CFR Part 11)

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Which Normality Test more acceptable to FDA; Also, Non-Normal Threshold?
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5
Views
3,551
snakepitt
T
Medical Device Manufacturer Document Control Computer System Validation
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4
Views
3,079
sagai
B
Autoclave Revalidation Methods
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5
Views
3,973
Brotri
D
Verification Requirements in a Machining Process
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6
Views
2,452
RogerG
V
Do we need to Validate a Server/Back-End System?
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2
Views
2,090
Gert Sorensen
R
CLIA Equipment or Software Validation Requirements
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5
Views
6,556
AtlQA
F
Measurement of (Validation of) Residual Disinfectant in the Air
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4
Views
2,179
Hydrazine
R
Conductivity Meter Qualification Guide
Replies
1
Views
4,417
Marc
V
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
Replies
1
Views
4,486
Stijloor
P
Process or Performance Qualification Requirements
Replies
5
Views
3,763
Patzer
A
Performance Qualification For Destructive Testing (Impact Testing)
Replies
4
Views
2,639
ash500
R
Qualification of Water Bath & pH Meter
Replies
5
Views
11,498
rameshpednekar
C
Equivalence Studies - Validation Activities for several Identical Pieces of Equipment
Replies
2
Views
2,478
Juan Dude
Q
IQ, OQ, PQ and Process Validation Sequence
Replies
5
Views
8,744
Doug Tropf
Q
Validation of X-RAY Process used in detecting voids in castings
Replies
9
Views
3,229
TamTom
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