Qualification and Validation (including 21 CFR Part 11)

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Periodic Review of Process and Equipment Validation
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4
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9K
Ajit Basrur
Ajit Basrur
T
Traceability of Requirements in the V-Model
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3
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8K
Ajit Basrur
Ajit Basrur
K
Document Approvals and 21 CFR 11 - Electronic signatures and approvals
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6
Views
4K
WEHTTAM
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T
21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention
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4
Views
4K
madannc
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T
21 CFR Part 11 Compliance - Generation of Complete Copies of Records
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3
Views
3K
temujin
T
S
FDA Validation - Does one have to conduct validation for Computer Servers?
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8
Views
7K
Weiner Dog
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T
Incorporating the Use of a Specific Software in an SOP - Validation of QA Software
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4
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3K
Gert Sorensen
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M
Date Stamping for Electronic signatures
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3
Views
3K
Ajit Basrur
Ajit Basrur
S
Pharmaceutical & Validation Protocol Listings?
2
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16
Views
10K
Al Rosen
Al Rosen
S
Test Method Validation Help - New titration test method, not defined in the USP
Replies
2
Views
10K
chiragtilara
C
J
21 CFR Part 11 - Securing Electronic signatures using Adobe Acrobat
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1
Views
4K
Al Rosen
Al Rosen
F
SOP's & Part 11 - Including Sec 11.50 Signature Manifestations
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3
Views
5K
Al Rosen
Al Rosen
D
FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive
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2
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4K
Miner
Miner
P
Part 11 - Changes to a system validated to Part 11 - What to revalidate?
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1
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3K
Al Rosen
Al Rosen
C
Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion
Replies
7
Views
10K
nickh - 2011
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