Qualification and Validation (including 21 CFR Part 11)

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Part 11 Hybrid System - Partial paper based record but with e-signature
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4
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3,862
Phatkid
J
Critical Process Parameters vs. Critical Performance Parameters - Definitions
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2
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6,361
v9991
ScottK
Validation of SAP - Secondary Packaging Manufacturer
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8
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3,692
JaxQC
F
Aged Inspection Equipment Software has no Audit Trail - Validation of Software
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5
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2,939
Jerome
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Understanding of Process Validations - ISO 9001 Clause 7.5.2 Validation
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9
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7,094
blueboat
J
Shelf Life Validation for new Heat Impulse Medical Packaging Sealer
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2
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3,772
bio_subbu
M
GLP (Good Laboratory Practices) Requirement for Sterility Validations
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1
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4,394
Sam Lazzara
R
Software & 21 CFR Part 11 Back Toward Center Stage
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1
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2,008
Stijloor
Q
Medical Device Field Service Performance Inspection Process Validation
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1
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3,071
MIREGMGR
L
Validation and documentation activities required for a custom-made software
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2
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2,713
RussKing3
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Development of IOQ Protocols - Validation in the Pharmaceutical Industry
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3
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16,662
harry
W
Oven Leak Test Method - Integrity of the chamber to hold gas
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3
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2,891
tomvehoski
W
Is an Oven I/O/Q Validation Required or is Calibration Sufficient?
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7
Views
4,961
BradM
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Cleaning Validation Plans, Sampling, etc - Allergens in Food
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1
Views
3,180
Stijloor
C
Validation of OTS (Off-the-Shelf) Training Software - Necessary?
2
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13
Views
5,474
Calico
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