Date Published:
Mon, 10/01/2007Warning Letter refers the clinical investigator to FDA's Guidance for Industry, Computerized Systems Used in Clinical Investigations for information on electronic record keeping obligations
Regulatory Actions
All Medicus, 8/07
Date Published:
Wed, 08/29/2007Warning Letter citation referring to failure to have procedures to validate medical device software for intended use.
Arrow International, 10/07
Date Published:
Wed, 10/10/2007Warning Letter describing 2 cases of failure to validate systems used as part of production or the Quality System.
Dialysis Dimensions, 10/07
Date Published:
Tue, 10/02/2007Warning Letter noting failure to re-validate system after remote changes.
Leiner Health Products, 8/07
Date Published:
Wed, 08/29/2007Warning Letter citation pertaining to undocumented reassignment of system administrator access resulting in unexplained data manipulation.
Eli Lilly, 2/01
Date Published:
Fri, 02/23/2001483 observation regarding the need for code review, security procedures, back-ups, and data archival for a lab system. Four examples included.
Schering-Plough Products, 2/16/01
Date Published:
Fri, 02/16/2001483 observation noting data integrity issues. Three examples cited.
Concord Laboratories, 7/06
Date Published:
Tue, 07/11/2006Warning Letter with several examples of system security failures.
Care Products, 7/06
Date Published:
Mon, 07/10/2006Warning Letter citation pertaining to the complete loss of 8 years worth of records.
Cardinal Enterprises, 12/01
Warning letter identifying lack of authenticity check on computer generated records.
