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 ...

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.

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 ...

SAN DIEGO, CA / ACCESSWIRE / September 17, 2024 / XiltriX North America is the only real-time environmental monitoring ...

Working from the instrument or PC and LabX will ensure that you are fully compliant with regulatory standards such as FDA 21 CFR Part 11. Use the services offered from METTLER TOLEDO for software ...

Applications for proposed drug products where the rate (21 CFR 314.54(b)(2)) and/or extent (21 CFR 314.54(b)(1)) of absorption exceed, or are otherwise different from, the 505(j) standards for ...