Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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0
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9,503
Marc
Discussions
V
Is periodic-requalification relevant for laboratory instruments
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0
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136
v9991
G
RO/DI water system qualification
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3
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179
gowtham9191
D
Conductivity Water Samples testing temperature
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2
Views
171
Das022
Q
IQ / OQ and PQ Project template wanted
2
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15
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17,704
Albridge
P
Does FDA require certification for quality system internal audit for auditor?
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1
Views
656
yodon
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4 5
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42
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52,281
dee jay
Z
SAP Validation for Part 11 Compliance - Examples (executed protocols)
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6
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5,442
Ranzeeth
R
SAP B1 Computer System Validation
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0
Views
185
Ranzeeth
P
Is the second factor authentication (2FA) required for external users?
Replies
1
Views
151
yodon
S
21 CFR part 11 version differences
Replies
1
Views
227
yodon
M
Is validation required when consumables are changed
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7
Views
664
Black Ships
E
Validation of new LIMS (Laboratory Information Management System)
2
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15
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8,063
Satyakumarreddy
D
Validating Operating system
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4
Views
407
diogo19
J
Validation Sample Size for Tray Seal
Replies
4
Views
1,060
MSterling
D
GAMP CAT 5 Change Control
Replies
9
Views
433
yodon
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