Statements (34)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
clinical trials
medical device industry biotechnology industry pharmaceutical industry quality management systems manufacturing records regulated industries under FDA jurisdiction |
| gptkbp:citation |
gptkb:21_CFR_§_11
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:enforcedBy |
gptkb:FDA
|
| gptkbp:fullName |
gptkb:Title_21_of_the_Code_of_Federal_Regulations_Part_11
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR Part 11
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:language |
English
|
| gptkbp:purpose |
establish criteria for electronic records and electronic signatures
|
| gptkbp:regulates |
electronic records
electronic signatures |
| gptkbp:relatedTo |
data integrity
GxP compliance FDA inspections predicate rules |
| gptkbp:requires |
audit trails
user authentication system validation access controls record retention training of personnel electronic signature linking secure, computer-generated, time-stamped audit trails |
| gptkbp:startDate |
1997
|
| gptkbp:bfsParent |
gptkb:OpenText_Core_for_Life_Sciences
gptkb:Veeva_Systems |
| gptkbp:bfsLayer |
6
|