When the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997,1 the internet existed but it was not as ubiquitous as it is today. Google wasn’t around yet. Life science companies ...

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This helps organizations reduce the cost of managing and documenting ...

Dublin, Jan. 20, 2025 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Compliance for SaaS/Cloud Application ... The instructor reviews recent FDA inspection trends and discusses how to streamline document ...

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 ...

# This conformance pack helps verify compliance with Title 21 CFR Part 11 requirements. # See Parameters section for names and descriptions of required parameters.

Analyses with Vision Air are completely traceable and meet the requirements of the FDA 21 CFR part 11 for the pharmaceutical industry. Vision Air is easy to command. Two clicks is all that is ...

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 ...