Statements (55)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
gptkb:contract_research_organizations
medical device industry biotechnology industry pharmaceutical industry closed systems open systems sponsors of clinical trials quality management systems manufacturing records FDA-regulated manufacturers electronic submissions to FDA laboratory records regulated clinical trials software vendors serving regulated industries |
| gptkbp:citation |
gptkb:21_CFR_Part_11
|
| gptkbp:enforcedBy |
1997
|
| gptkbp:fullName |
Title 21 Code of Federal Regulations Part 11
|
| gptkbp:guidanceSystem |
FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA 21 CFR Part 11
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:purpose |
to ensure the trustworthiness and reliability of electronic records and signatures
|
| gptkbp:regulates |
electronic records
electronic signatures |
| gptkbp:relatedTo |
gptkb:Good_Clinical_Practice_(GCP)
gptkb:Good_Laboratory_Practice_(GLP) gptkb:Good_Manufacturing_Practice_(GMP) data integrity regulations |
| gptkbp:requires |
audit trails
user authentication data integrity system validation access controls record retention training of personnel change control system documentation documented procedures electronic signature linking unique user identification secure, computer-generated, time-stamped audit trails record copying electronic signature controls open and closed system controls password controls protection of records record retrieval signature manifestation signature/record linking system checks |
| gptkbp:section |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:subject |
enforcement actions
FDA inspections |
| gptkbp:bfsParent |
gptkb:GAMP
|
| gptkbp:bfsLayer |
7
|