FDA05
SASŪ Coexistence with FDA 21 CFR Part 11, how far can we get?
Gustav Sporon-Fiedler, H. Lundbeck A/S
Marie Lassen, H. Lundbeck A/S

FDA 21 Part 11 presents a number of requirements that challenge the standard usage of SAS in the scientific communities within pharmaceutics. This paper examines SAS techniques and configurations which may help the SAS user community get closer to complia nce requirements. The standard consolidated SAS environment is non compliant with FDA 21 Part 11. A number of add on facilities and non SAS products are needed to achieve compliance regarding such items as security and version control. However SAS does s upply excellent audit trail and log facilities that should be fully exploited when attempting to comply with the requirements as set by FDA 21 CFR Part 11.