Product: Sirolimus-Eluting Coronary Stent
Failure to validate with a high degree of assurance, processes, including changed processes, that cannot be fully verified by subsequent investigation and test, as required by 21 CFR 820.75(a) & (c). For example:
The automated [redacted] data acquisition system, used to ensure the integrity of the analytical data generated from laboratory chromatography equipment, was not adequately validated for its intended use. The validation did not include testing and verification of backup and restoration of the electronic data files.
Issuing Office: CDRH