Validation Center™

Warning Letter observation regarding the lack of documented specifications and testing for medical device software

Warning Letter citations including lack of system validation, risk analysis, and documentation.

Warning Letter citing multiple examples of CAPA process failure for software used in medical devices.  Includes failure to investigate software vendor processes.

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).

Warning Letter highlighting failure to address training on CAPA system changes.

Warning Letter noting failure to follow procedures when using a quality system database.

Warning Letter citing failure to back-up and retain laboratory system data.

Warning Letter noting failure to address deficiancies in a system's suitability for intended use.

Warning Letter describing failure to perform system integration testing and code review prior to software change.

Warning letter citation noting failure to perform risk analysis and structural testing of software embedded in a medical device.