U.S. Department of Health and Human Services
Food and Drug Administration (FDA)
Office of the Commissioner (OC)
May 2007
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND............................................................................................................... 2
III. SCOPE ............................................................................................................................... 3
IV. RECOMMENDATIONS.................................................................................................. 3
A. Study Protocols ..............................................................................................................................3
B. Standard Operating Procedures...................................................................................................3
C. Source Documentation and Retention..........................................................................................4
D. Internal Security Safeguards ........................................................................................................4
1. Limited Access ................................................................................................................................4
2. Audit Trails .....................................................................................................................................4
3. Date/Time Stamps ............................................................................................................................5
E. External Security Safeguards .......................................................................................................5
F. Other System Features ..................................................................................................................6
1. Direct Entry of Data ........................................................................................................................6
2. Retrieving Data...............................................................................................................................6
3. Dependability System Documentation ............................................................................................. 6
4. System Controls ...............................................................................................................................6
5. Change Controls ..............................................................................................................................7
G. Training of Personnel ....................................................................................................................7
DEFINITIONS............................................................................................................................. 8
REFERENCES............................................................................................................................. 9
APPENDIX A.............................................................................................................................. 10