Company: Tecan US
Product: Tecan Clinical Workstation and Tecan Genesis RSP
Date: 10/8/04
Failure to have complete validation of the _____ software program, as required by 21 CFR 820.30(g). Your firm did not have documentation of complete requirements specifications and software design specification for the entire _____ software program. Documentation of the software program provided by the original developer of the software was limited and did not show a complete validation of the software program. Additionally, validation of the software upgrades was limited to the changes or additions made to the software program by the upgrades. Validation has not been conducted on the entire _____ software program. Test cases only tested the software modifications with no references or linkage to an overall software program validation. (FDA 483 item #1)
Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a)(4). Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device. Specifically, your firm implemented two corrective actions in response to potential patient sample mismatches occurring with the use of the Tecan Clinical Workstation with _____ software. These corrective actions included a manual workaround for patient sample identification and new purging instructions. Your firm failed to verify or validate these corrective actions prior to implementation in the field. (FDA 483 item # 2 & 13)
Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). There were no overall design procedures. Your firm did pot have any written design control procedures in place. Your firm did not have procedures for making or controlling software changes during the software development process. (FDA 483 item #3)
We acknowledge receipt of your letters dated May 28, 2004, June 14, 2004, June 29, 2004, July 26, 2004, and August 31, 2004 which were in response to the FDA 483. Your responses are currently being reviewed and will be addressed in a separate letter. We also acknowledge that you indicated in your June 29, 2004 letter that relevant software, engineering, manufacturing, integration and assembly personnel will be transferred to your sister facility, Tecan Systems, in San Jose, CA. You may refer to your responses in your answer to this Warning Letter. Please send your response to the attention of Serene N. Ackall, Compliance Officer at the address noted in the letterhead. If you have any questions about this letter, you can contact Serene Ackall at 404-253-1296.
FDA District: Atlanta District Office
