Validation Center™

Warning letter quoting company personnel as reporting that data was lost in a systme upgrade.

This Warning Letter requests additional information regarding validation and employee training on a new software application.

Warning Letter citing two failures to validate that systems were suitable for their intended purpose.

Warning Letter noting failure to verify spreadsheet calculations used to release products.

Warning Letter requesting procedures and training records regarding an electronic system for inventory and shipping records.

Warning Letter noting failure to generate or retain documentation to corroborate data in the electronic system.

Warning Letter citing failure to approve software changes prior to implementation.

Warning Letter requesting additional information on the company's use electronic means to replace physical label copies in the master batch record.

Warning Letter citation noting failure to adequately address use of an electronic complaint handing system in an SOP.

Warning Letter citing inadequate device software validation, CAPA investigation, and corrective action.