a. The reason for changes made to the CNC software programs was not documented nor signed off by a designated individual.
b. When the CNC software is changed, the previous versions are overwritten or lost, thus making traceability of the software’s evolution impossible.
4. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, the software program number and CNC machine identification were not recorded in the appropriate spaces on the instrument records.
7. Failure of the device master record to include production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications, as required by 21 CFR 820.181(b) . For example, specification ranges for the X, Y, and Z dimensions in the CNC machine software for each instrument have not been defined in the device master record.
b. The software program number and CNC machine identification were not recorded in the appropriate spaces on the instrument records in the device history records.