We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Maintaining Data Integrity.
- Authors
Pérez, José Rodríguez
- Abstract
The article discusses the release of data integrity draft guidance document by the U.S. Food and Drug Administration (FDA) in April 2016. It suggests that controlled and numbered forms should be issued and reconciled by quality assurance (QA) for recording data. It cites that any findings of data integrity violations and remove individuals who are responsible for data integrity problems from current good manufacturing practices positions should be disclosed to the FDA.
- Subjects
QUALITY assurance; INTEGRITY; DATA security; CURRENT good manufacturing practices; UNITED States. Food &; Drug Administration
- Publication
Quality Progress, 2017, Vol 50, Issue 3, p14
- ISSN
0033-524X
- Publication type
Article