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[13]Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
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- f-411-part11-scope-final.pdf(214.9K)[16]2014-08-02 21:39:02
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
Office of Regulatory Affairs (ORA)
August 2003
Pharmaceutical CGMPs
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND............................................................................................................. 2
III. DISCUSSION................................................................................................................ 3
A. Overall Approach to Part 11 Requirements...............................................................3
B. Details of Approach – Scope of Part 11 ...................................................................4
1. Narrow Interpretation of Scope ....................................................................................4
2. Definition of Part 11 Records .......................................................................................5
C. Approach to Specific Part 11 Requirements ..............................................................6
1. Validation.........................................................................................................................6
2. Audit Trail..........................................................................................................................6
3. Legacy Systems ..............................................................................................................7
4. Copies of Records ...........................................................................................................7
5. Record Retention...............................................................................................................8
IV. REFERENCES............................................................................................................... 9
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