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Software Validation in Clinical Trial Reporting ...

Software Validation in Clinical Trial Reporting : Software Validation in Clinical Trial Reporting : Experiences from the Experiences from the BiostatisticalBiostatistical& data & data sciences DepartmentSciences DepartmentAndrea BakerAndrea BakerSenior ProgrammerSenior ProgrammerGlaxoSmithKlineGlaxoSmithKline SeUGI 19 FlorenceMay 29-June 1 2001 IntroductionIntroduction This presentation will provide an overview of Validation and how Validation processes can be applied to Clinical Trial Reporting Software and will include: Why validate? What is Validation ? What Validation isn t What does Validation involve? Implementing a Validation process Conclusions/ConsiderationsWhy Validate?

Software Validation in Clinical Trial Reporting: Experiences from the Biostatistical & Data Sciences Department Andrea Baker ... Validation in Clinical Research A Practical Guide: ... Validation Guide Document Revision 1.1

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