Review of the _____ which consisted of the software and hardware components necessary to _____ DHRs and maintain them as electronic records, revealed the following:.
Changes to processes were not always reviewed and evaluated or revalidated, where appropriate, and documented [21 CFR 820.75(c)], in that the software validation dated _____ was completed for software _____ The current software _____ in use was _____.
Documents were not always approved and distributed by a designated individual [2 1 CFR 820.40(a)], in that, _____ of DHRs began in _____, and there was no documented approval that allowed the DHRs to be _____. In addition, the software validation was not completed until _____.
For your information, during the inspection our Investigator also noted there is no assurance that the _____ could create an audit trail that was computer generated and time stamped to independently record the date and time of operator entries and action as required by 21 CFR 11.10(e).
