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By Trenton Thiede, PharmD, MBA, President at PAAS National, expert third party audit assistance and FWA/HIPAA compliance

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Generation of whole-body Glp-1r / mice by Rosa26Cre -mediated excision confirms utility of the LoxP sites incorporated within the knock-in locus, a feature that will allow conditional gene deletion strategies in the future

Thus, a firm can possess modern instrumentation and still fail CGMP if it cannot demonstrate: (i) attributable actions (unique users), (ii) tamper-evident records (audit trails that cannot be disabled and are meaningfully reviewed), (iii) record permanence (prevent/controls over deletion plus validated backups), and (iv) verified correctness of input/output and calculations (including spreadsheet validation and retention)