Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA

被引：2

作者：

Arfvidsson, Cecilia ^{[1
]}

Van Bedaf, David ^{[2
]}

Doig, Mira ^{[3
]}

Globig, Susanne ^{[4
]}

Knutsson, Magnus ^{[5
]}

Lewis, Mark ^{[6
]}

McDougall, Stuart ^{[7
]}

Michi, Marco ^{[8
]}

Mokrzycki, Nathalie ^{[9
]}

Timmerman, Philip ^{[10
]}

机构：

[1] AstraZeneca R&D, Gothenburg, Sweden

[2] Janssen R&D, Beerse, Belgium

[3] ABS Labs, Welwyn Garden City, Herts, England

[4] Idorsia Pharmaceut Ltd, Allschwil, Switzerland

[5] Ferring, Copenhagen, Denmark

[6] GlaxoSmithKline R&D, Ware, Herts, England

[7] ARCinova, Alnwick, England

[8] Aptuit, Verona, Italy

[9] MSD, Clermont Ferrand, France

[10] European Bioanal Forum Vzw EBF, Havenlaan 86c B204, B-1000 Brussels, Belgium

来源：

BIOANALYSIS | 2019年 / 11卷 / 13期

关键词：

audit trail; data integrity; data transfers; EBF;

D O I：

10.4155/bio-2019-0139

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

In this conference report, we summarize the main findings and messages from a workshop on 'Data Integrity'. The workshop was held at the 11th European Bioanalysis Forum Open (EBF) Symposium in Barcelona (21-23 November 2018), in collaboration with the Medicines and Health products Regulatory Agency to provide insight and understanding of regulatory data integrity expectations. The workshop highlighted the importance of engaging with software developers to address the gap between industry's data integrity needs and current system software capabilities. Delegates were also made aware of the importance of implementing additional procedural controls to mitigate the risk associated with using systems that do not fully meet data integrity requirements.

引用

页码：1227 / 1231

页数：5