Warning Letter: System not validated (ucm243585)

In addition, we remain concerned that your [redacted] adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is still not final. Critical issues (deviations) identified in your interim validation report during the inspection included the following, but is not limited to: lack of training for your [redacted] support team, incomplete SOPs and Work Instructions, and inaccurate data migration of legacy adverse experience cases from your previous adverse drug experience database, [redacted]. Currently, your [redacted] system does not display accurate clock dates on MedWatch forms for cases which were initially entered in [redacted] and later entered into [redacted] due to the receipt of additional information (follow-up) for the same cases. MedWatch forms printed out from [redacted] for these migrated cases are documented as initial 15-day reports, instead of follow-up reports. Also, the report date in Block B5 of the MedWatch form is the print date, not the actual date of submission. Shortcomings such as these affect the accuracy, reliability, consistency of the system and your firm’s ability to discern invalid or altered electronic records or make timely submissions to FDA as required.

View the original warning letter.