Warning Letter: Failure to ensure design validation documented user needs and intended uses (ucm558078)

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Ofni Systems

For Change Notice CN 517 approved on July 8, 2016, your documentation of validation testing did not include the date the testing was conducted for software part numbers PGM358R15, PGM359, and PGM361.

Your response states that you will be performing verification of the software changes made to your device; however, your response does not explain whether you will also be performing validation of these changes…

Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). For example, during our review of seven Change Notices (CN) for the NetViewer MDP2040-0100 device, it was observed that two of the CNs did not document verification that the outputs met design objectives:

a. For Change Notice CN 517 approved July 8, 2016, your firm identified design objectives including “[redacted] compliance;” however, your firm did not document that updated hardware and software were in compliance with this objective.

b. For Change Notice CN 527 approved September 4, 2015, your firm identified design objectives for software [redacted] to provide “[redacted];” however, your firm did not document the updated software met this objective.

The adequacy of your firm’s response cannot be determined at this time.  Your response states that you will conduct verification and validation regarding the [redacted] compliance and the software changes; however, your response does not provide interim measures you will be taking prior to the completion of the validation in June 2017.  Your response reiterates the creation of a new verification and validation procedure; however, it does not provide details on how your firm plans on verifying the effectiveness of this procedure to ensure it prevents the noted violation from recurring…

a. Your firm’s DMR effective June 3, 2016, to January 9, 2017, for the NetViewer MDP2040-0100 device did not contain or reference specifications, procedures and labeling used to manufacture the device including: specifications for the internal speaker component; updated versions of Drawing FMP0000283-FRONT and Drawing FMP0000269-REAR; software PGM358R15 released July 8, 2016; the updated version of MDP2040-0100 BUILD PROCEDURE; and the updated version of the Operation Manual.

b. Your firm’s DMR effective March 17, 2016, to June 3, 2016, for the NetViewer MDP2040-0100 device did not contain or reference software PGM355R8 released on March 11, 2016.

View the original warning letter.


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