Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:alsoKnownAs |
Part 11
|
| gptkbp:appliesTo |
medical device industry
biotechnology industry pharmaceutical industry |
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR § 11
|
| gptkbp:jurisdiction |
gptkb:United_States
|
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:purpose |
to ensure the trustworthiness and reliability of electronic records and signatures
|
| gptkbp:regulates |
electronic records
electronic signatures |
| gptkbp:requires |
audit trails
user authentication record retention system documentation validation of systems |
| gptkbp:startDate |
August 20, 1997
|
| gptkbp:bfsParent |
gptkb:21_CFR_Part_11
|
| gptkbp:bfsLayer |
7
|