Back to Search
Start Over
How Important is Data Integrity to Regulatory Bodies?
- Source :
- Pharmaceutical Technology; Mar2016, Vol. 40 Issue 3, p50-76, 5p
- Publication Year :
- 2016
-
Abstract
- The article focuses on the regulatory issue and concerns on data integrity in good manufacturing practice (GMP)-regulated laboratories. Topics discussed include the focus of inspection on electronic records and computerized systems, the non-compliance to European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), and the use of laboratory information management system (LIMS) for data management and documentation.
Details
- Language :
- English
- ISSN :
- 15432521
- Volume :
- 40
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Pharmaceutical Technology
- Publication Type :
- Periodical
- Accession number :
- 113756012