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Data Integrity Expectations of EU GMP Inspectors: The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

Authors :
López, Orlando
Source :
Pharmaceutical Technology Europe; Jul2017, Vol. 29 Issue 7, p6-10, 4p
Publication Year :
2017

Abstract

The article focuses on technological expectation of European Union computer systems performing good manufacturing practices (GMP) related functions is terms of data integrity of electronic records. It mentions that properly recorded and managed electronic information and metadata serve as basis for manufacturers to assure their products' identity, quality and safety. It also states the responsibility of European Medicines Agency to regulate medicinal products within the European Commission.

Details

Language :
English
ISSN :
17537967
Volume :
29
Issue :
7
Database :
Complementary Index
Journal :
Pharmaceutical Technology Europe
Publication Type :
Periodical
Accession number :
124159544