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PDA TR 80

Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories

Report / Survey by Parenteral Drug Association , 08/01/2018

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Full Description

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.
 

Product Details

Published:
08/01/2018
ISBN(s):
9781945584053
Number of Pages:
63
File Size:
1 file , 2.6 MB
Product Code(s):
01080