Quality Risk Management Approach for computer system validation

GAMP 5 Quality Risk Management Approach

Out of Specification (OOS) Investigations for GLP Nonclinical Studies

Out of Specification (OOS) Investigations for GLP Nonclinical Studies

Data Integrity: Success by Design - Fat-finger, Falsification and Fraud"

Data Integrity: Success by Design - Fat-finger, Falsification and Fraud"

Data Integrity-By Karen-Takahashi

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Warning Letters Demonstrating
Data Integrity Problems
2014 PDA Annual Meeting
March 7, 2014
Karen Takahashi
Senior Policy Advisor
FDA/CDER/Office of Compliance

karen.takahashi@fda.hhs.gov

FDA’s Increasing Focus on Data Integrity

Computer System Validation

Computer System Validation Lifecycle V-model

"Agile" Over view [PPT]

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PRINCIPLES OF SOFTWARE VALIDATION BY USFDA

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ISPE Risk based approach to 21 CFR PART 11

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21CFR Part 11 sample check list

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Difference between 21 CFR Part 11 and EU Annex 11

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