Date Published:
Fri, 10/11/2002483 observations on lack of Standard Operating Procedures (SOPs) for system operation and maintenance, system and network security, QA oversight of the LAN, and IT training.
483s
Abbott Health Products, 12/99
Date Published:
Thu, 12/16/1999483 observations noting failure to have adequate controls for authenticity and integrity of lab data. Four examples are listed.
3M Pharmaceuticals, 9/99
Date Published:
Fri, 09/24/1999483 observation on undocumented software upgrades.
