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Erqou S, Kaptoge S, Perry PL, Di Angelantonio E, Thompson A, White IR, Marcovina SM, Collins R, Thompson SG, Danesh J

Cell 92 , 735745 (1998)

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))." 7 Detailed Analysis of the Violation The "Administrator Rights" Epidemic: Laboratory staff were granted "administrator rights," which allowed them "uncontrolled access to delete or modify files" on HPLC, GC, and FTIR systems.7 The FDA explicitly noted the lack of "segregation of firm personnel involved with laboratory testing from those with administrator rights".7 This violation mirrors those seen in the US and China, indicating a global challenge in managing legacy instrument software where "Admin" access is often the default setting required to run the instrument

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