מה זה  21CFR ?
תקן 21CFRPart11 הוא קיצור של Code of Federal Regulation,
מכיל בתוכו את מערכת החוקים של מדינת ארה”ב ומחולק ל 50 כותרים ( Titles)
בהקשר לעניינו CFR-21 הוא קובץ הנחיות המתייחס לרישומים האלקטרוניים והחתימה האלקטרונית במערכות אוטמציה ובקרה. תעשייני הפארמה מכירים את קובץ הנחיות זה המשמש כמרכיב עיקרי במלאכת הולידציה של מערכות מפוקדות.

CFR - Code of Federal Regulations Title 21
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records andelectronic signatures are considered to be trustworthy, reliable, and equivalent to paper record.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

מה זה NIST  ?

The National Institute of Standards and Technology (NIST) was founded in 1901 and is now part of the U.S. Department of Commerce. NIST is one of the nation's oldest physical science laboratories. Congress established the agency to remove a major challenge to U.S. industrial competitiveness at the time—a second-rate measurement infrastructure that lagged behind the capabilities of the United Kingdom, Germany, and other economic rivals.

From the smart electric power grid and electronic health records to atomic clocks, advanced nanomaterials, and computer chips, innumerable products and services rely in some way on technology, measurement, and standards provided by the National Institute of Standards and Technology.

Today, NIST measurements support the smallest of technologies to the largest and most complex of human-made creations—from nanoscale devices so tiny that tens of thousands can fit on the end of a single human hair up to earthquake-resistant skyscrapers and global communication networks
https://www.nist.gov/