Societa Italiana Mediciniali Scandicci 12/6/00 APIs
…The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete….
We have also reviewed your November 3, 2000 written response to the FDA-483…
Your proposed corrective actions for deficiencies 2, 3, and 4 regarding validations appear satisfactory except that the validations will not be completed until the end of March, 2001 and imply that you would continue to use the unvalidated computer systems and equipment cleaning methods until then.
SoftwareCPR Keywords: Human Drugs