This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory. It is intended to outline regulatory requirements and expectations, along with best industry practices, to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation.
Document identifier
PDA TR 80
Title
Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories
Publication date
2018-08-01
International Relationship
| Price |
325 vnd |
.jpg){kind=logo}
---Logo.jpg){kind=logo}
.jpg){kind=logo}
-_-logo.png){kind=logo}
.jpg){kind=logo}
.png)
