3. The software was changed, consistent with the new performance specifications.
2. Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example:
a) The validations were not documented for the computer software used to control the in-process inspection for the motor component of the H-TRONplus;
b) The computer software used to control the in-process testing of the LP Mainboard V 1.0 was not validated for the test performed documented.
3. Failure to have specification changes approved and documented by a designated individual(s) including an approval date and the date the change becomes effective, as required by 21 CFR 820.100(a)(2). For example, software changes made from the H-TRON V100 to the H-TRONplus V100 have not been adequately validated in that the complete set of parameters, including all alarms, have not been tested.
