Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory compliance standard
|
| gptkbp:appliesTo |
electronic records
electronic signatures |
| gptkbp:codifiedIn |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:dateEnacted |
1997
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR Part 11 compliance
|
| gptkbp:purpose |
ensure trustworthiness and reliability of electronic records
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
audit trails
medical device industry biotechnology industry data integrity pharmaceutical industry system validation user access controls record retention training of personnel documentation of procedures secure electronic signatures |
| gptkbp:section |
Part 11
|
| gptkbp:bfsParent |
gptkb:Benchling_Life_Sciences_R&D_Cloud
|
| gptkbp:bfsLayer |
7
|