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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7,037
Marc
Discussions
V
Process, component or full product re-qualification: leaded to unleaded solder
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7
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175
Miner
S
Heat Sealers Upper and lower limit setting during OQ for Heat Sealer
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0
Views
73
Silvia tiozzo
M
Is Validation of Plating Processes required and who is responsible?
2
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10
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306
outdoorsNW
Q
Validation Guidance - Plastic Injection Molding Process
2 3 4
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34
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46,233
apacor_sv
D
DQ documents of new equipment - Function specification
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0
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225
Duyen
S
Rees System Validation
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1
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193
Ajit Basrur
D
CSV - Periodic Review
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1
Views
215
yodon
I
Cleanroom Actions in case of Actions Limit Alarm
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3
Views
903
Dasha
S
Validation Records - Very young QMS
Replies
2
Views
472
yodon
D
Performance of high shear mixer (or rapid mixing granulator
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4
Views
344
Duyen
S
Computer System Validation of Bioinformatics Pipeline
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5
Views
675
yodon
Z
Qualification of AzureDevOps in Gxp
2
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12
Views
993
sreekiran14
F
Bayes Success run Theorem for sample size during OQ&PQ
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4
Views
838
Aaron M
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
2
Replies
12
Views
5,581
v9991
P
Periodic Review - Deviations/incidents that are reviewed
Replies
5
Views
1,126
v9991
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