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.

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.

Warning Letter noting use of uncontrolled electronic copies of documents.