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  • Warning Letter: No documentation of software validation results (ucm247475)

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    Ofni Systems

    Documentation of all software validation results  for the i.v.STATION was not completed per your firm’s Design Control, (D R&D 33.00) and the Design and Development Planning (P R&D 01.01) procedures. For the [redacted]  software validation test, the output is to verify that the procedure was completed correctly and that the “bag contains the requested volume of the drug.” The test completion date and the volume of the drug were not recorded. Additionally, successful completion of the [redacted]software validation test is to verify “that the syringe contains the required volume of drug.” The completion date and the volume of the drug in the syringe were not recorded, per procedure, for this test as well.

    View the original warning letter.


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