Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:abbreviation |
gptkb:QSR
|
| gptkbp:appliesTo |
manufacturers of medical devices
|
| gptkbp:basedOn |
gptkb:Good_Manufacturing_Practice
|
| gptkbp:codifiedIn |
21 CFR Part 820
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
Quality System Regulation
|
| gptkbp:purpose |
ensure medical devices are safe and effective
|
| gptkbp:regulates |
medical devices
|
| gptkbp:requires |
records management
document control internal audits quality management system corrective and preventive actions handling, storage, distribution, and installation controls design controls labeling and packaging controls production and process controls purchasing controls servicing controls |
| gptkbp:startDate |
June 1, 1997
|
| gptkbp:bfsParent |
gptkb:current_Good_Manufacturing_Practice
gptkb:FDA_21_CFR_Part_820 |
| gptkbp:bfsLayer |
8
|