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 ...

To address potential risks of unauthorized alterations, the FDA implemented 21 CFR Part 11 in March 1997, establishing that electronic records and signatures must be as secure and tamper-resistant ...

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some ...

This guidance provides the agency’s current thinking on establishing a routine sanitation program for low-moisture, ...

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 ...