Pointée du doigt dans cette nouvelle mise en demeure d'un laboratoire pharmaceutique :
6. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
Your firm’s (b)(4) “Jasco LC-Net II” HPLC instruments do not have restrictions in place to prevent any change or deletion of analytical raw data. Additionally, there is no audit trail in place to determine any previous deletion of raw data.
We acknowledge that you have discontinued usage of all Jasco systems in SFF and other sites effective June 26, 2013, and will assess previous use of the Jasco systems. In your response, please submit an assessment of the integrity of the data from the Jasco systems only for lots of finished product still within expiry as of the date of this letter.