Ensuring Compliance with 21 CFR Part 11

Feliciano-Welpe, Diane; Katzer, David
July 2003
Heating/Piping/Air Conditioning Engineering;Jul2003 Supplement, Vol. 42, p60
Provides information on 21 CFR part 11, the guidelines for data integrity and accountability in submitting and storing information electronically developed by the U.S. Food and Drug Administration. Basic qualifications of electronic records; Types of electronic records that provide information about Current Good Manufacturing Practice and Good Laboratory Practice environments for building automation and control systems; Requirements in developing a program to achieve compliance with 21 CFR part 11 as it relates to building automation systems. INSET: The Many Faces of Information.


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