A new PerkinElmer publication "21 CFR Part 11 - A Primer For Analytical Laboratories" discusses in detail all the requirements of the rule, with the steps required to develop compliant systems
A new PerkinElmer publication "21 CFR Part 11 - A Primer For Analytical Laboratories" discusses in detail all the requirements of the rule, with the steps required to develop and implement technically compliant systems.
21 CFR Part 11 is the Food and Drug Administration (FDA) Rule relating to the use of Electronic Records and Electronic Signatures and has important implications for the pharmaceutical and other highly regulated industries.
It covers electronic records and electronic signatures for all products sold in the United States.
Many computer systems used within these regulated industries, including process control equipment, documentation control and laboratory data records, must comply.
PerkinElmer Instruments offers a growing number of 21 CFR Part 11 compliant solutions.
Enhanced Security software is currently available for its LC, GC, FT-IR, FT-NIR, UV/Vis, DSC, TGA, AA and ICP platforms.
