Qualification and Validation (including 21 CFR Part 11)

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SOP for Audit Trail Comments
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v9991
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For Analytical Laboratory Equipment, is PQ = Calibration Criteria?
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BradM
BradM
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Is a formal review after OQ (in Process Validation) required?
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kuyakut
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Deviating from USP Method for Microbiological Assay
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ben83
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Class III Medical Device Qualification in Phase 2?
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Marcelo
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Validation Test and Acceptance Criteria for Compressed Air
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Marc
Marc
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Performance Qualification of old Rapid Mixer Granulator
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P- HK
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Process Validation, NPD (New Product Development), and Supplier Management
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patilrahuld
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21 CFR Part 11: Electronic Signatures
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szohar
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Compliance with CFR 21 Part 11 vs. ISO 9001 Certification
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9
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v9991
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IQ Requirements for Old (10 yrs) Commissioned Equipment
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2
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QAengineer13
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Requirements for Qualifying a Stability Chamber
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v9991
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ScottK
Signing documents with a stylus on a tablet
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maaquilino
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Maintaining an E-Record for Equipment Data
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v9991
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Drift and Variation over Time of an Analytical Balance.
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v9991
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