The iQue ® software module for 21 CFR Part 11 ensures next-level iQue ® productivity for regulated laboratories. Designed for speed and actionable results, iQue ® is the instrument of choice ...
DeNovix Inc. announces the launch of EasyApps Secure, a 21 CFR Part 11 Compliance Ready software option for CellDrop Automated Cell Counters. The new suite of controls for EasyApps software enables ...
including deficiencies tied to 21 CFR Part 11, 6 which governs electronic records, systems and signatures of FDA-regulated entities (see our recent alert on the updated Part 11 FDA guidance).
See 21 CFR parts 11, 54, 210, 211, 312; the FDA Center for Drug Evaluation and Research; and UAB HRPP PRO121 Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets ...
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