Medical Information Technology 3/6/97 Blood Bank Software Manufacturer
c. Quality Assurance audits do not cover any quality assurance activities associated with the software customization program.
4. Failure to establish an adequate complaint handling program for the [purged text] as required by 21 CFR 820.198 in that complaints are not reviewed by a formally designated unit and complaints which relate to a possible hazard to safety are not kept in a separate portion of the complaint file.
5. Failure to establish an adequate personnel training system as required by 21 CFR 820.25 in that there is not documentation of training and personnel are not aware of the GMP and MDR regulatory requirements under which your firm is required to operate.
6. Failure to assure that the device specification changes are subject to controls as stringent as those applied to the original design, as required by 21 CFR 820.100, in that software defects were identified by users rather than identified during your software validation activities. Examples of these defects include such significant software elements as donor antibody history, ([purged text]) and donor blood type ([purged text]).