Warning Letter on Software Validation added to the Ombu Library

The Ombu Library has analysis and recommendations of a Warning Letter for failure to validate software used in the company‚Äôs QMS as required by §820.70(i). In this Warning Letter, a company developed software for documenting and monitoring nonconformances with customer complaints, suppliers, internal/external audits, CAPA, and internal facility defects. However, during an inspection the FDA Investigator uncovered that they had not conducted validation.