Qualification and Validation (including 21 CFR Part 11)

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Marc
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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4,921
Marc
Forum Discussion Threads
I
GMP 21 CFR Part 11 Electronic Records Compliance Project Help
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7
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303
chris1price
M
Electronic Signature - Certificate
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8
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105
Ninja
L
Understanding FDA requirements for Software Validation
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6
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8,119
yodon
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
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5
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250
Mark Meer
I
Cleanroom Actions in case of Actions Limit Alarm
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1
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132
planB
E
Labware cleaning validation protocol example
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1
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158
v9991
Sam Lazzara
Time Zero testing in med device aging studies
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2
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147
planB
I
Quality of Potable Water Testing Parameters during Purified Water Validation
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1
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161
Ajit Basrur
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IQ, OQ, PQ and Validation Master List
2
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16
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25,472
bcoolnow
V
Tyvek packaging for Medical device process validation
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2
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1,102
vsethuram
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