Lex Inc. was issued a warning letter from the FDA for reason “of vulnerabilities in hardware and software, encompassing both networked and non-networked systems (e.g., programmable logic controller (PLC)).” More specifically, “a list of all software configurations (both equipment software and laboratory information management system (LIMS)) and versions, details of all user privileges, and oversight responsibilities for each of your laboratory systems. Regarding user privileges, specify user roles and associated user privileges (including the specific permissions allowed for anyone who has administrative rights) for all staff who have access to the laboratory computer systems, their organizational affiliation, and title. Also describe how you will ensure laboratory staff are not given administrative rights, or other permissions that compromise data retention or reliability. System security provisions including, but not limited to, whether unique usernames and passwords are always used, and their confidentiality safeguarded.”
For more information, see the link below.