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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Qualification and Validation (including 21 CFR Part 11)
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Test Method Validation Help - New titration test method, not defined in the USP
SarahRYMoore
Jun 8, 2006
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9,324
Jun 16, 2006
chiragtilara
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21 CFR Part 11 - Securing Electronic signatures using Adobe Acrobat
Jeanne
Jan 4, 2006
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3,717
Jan 4, 2006
Al Rosen
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SOP's & Part 11 - Including Sec 11.50 Signature Manifestations
fheatherly
Oct 4, 2005
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4,467
Nov 18, 2005
Al Rosen
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FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive
Douglas Cruz
Nov 6, 2005
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3,233
Nov 6, 2005
Miner
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Part 11 - Changes to a system validated to Part 11 - What to revalidate?
Pataha
Sep 7, 2005
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2,646
Sep 7, 2005
Al Rosen
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Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion
CCroft
Jul 7, 2005
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8,538
Aug 9, 2005
nickh - 2011
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