Warning Letter: Lack of system control (ucm075766)

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Ofni Systems

You failed to establish and maintain process control procedures , including documented instructions and written SOPs for steps in the testing of blood and blood components [21 CFR 606.100(b), 820.70(a)(1)]. Specifically: “a) There are no written procedures describing computer software[redacted] functional requirements or descriptions of functions and there is no computer manual. The database functions as the information management tool used to collect, organize, process, analyze, secure and maintain testing data. “We also note that you have failed to establish an adequate system for authorizing, granting, and rescinding computer access to functions in the [redacted] and adequate computer security provisions to assure data integrity. Current users do not use appropriate access such as passwords and user-id and personnel who have changed jobs still have access to the system.

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