WL Shriram Institute for Industrial Research APRIL 15, 2020
1. 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(a)).
Your firm serves as a contract testing laboratory analyzing both API and drug products. Your firm had not enabled the audit trail function on high-performance liquid chromatography (HPLC) units until on or about October 11, 2019, when this FDA inspection was announced.Your analyst acknowledged during the inspection that the audit trail function on the HPLCs units was not enabled until October 2019. This was a repeat observation of your August 2016 FDA inspection.
Despite written commitments after that inspection to install audit trails, you failed to enable audit trail functions on multiple analytical instruments, including your HPLC units.
Customers rely on the integrity of the laboratory data that you generate to make decisions regarding drug quality. It is important to maintain strict control over CGMP electronic data to ensure that all additions, deletions, or modifications of information in your electronic records are authorized and appropriately documented....
