This document summarizes and categorizes the number of US FDA 483s issued during fiscal year 2010 via the FDA's TURBO EIR system
Computer specific related regulations cited include 21 CFR 820.70(i), 21 CFR 820.30(g), 21 CFR 820.181(a), 21 CFR 211.68(a) and (b), 21 CFR 123.9(f), and 21 CFR 1271.160(d).
483 identifying multiple deficiencies in security, back-ups, and password protection for laboratory systems.
483 observation noting failure to validate a lab calculation
483 observation regarding the need for code review, security procedures, back-ups, and data archival for a lab system. Four examples included.
483 observation noting data integrity issues. Three examples cited.
483 observations pertaining to electronic records management and approval. Many examples are noted.
483 observations regarding QA oversight, security testing, and password maintenance. Four examples.
483 observation regarding lack of system documentation, programming standards, and testing. Detailed example is provided.
483 observations referring to a lack of spreadsheet formula protection, system procedures, and audit trails.
