Arfvidsson Cecilia, Bedaf David Van, Doig Mira, Globig Susanne, Knutsson Magnus, Lewis Mark, McDougall Stuart, Michi Marco, Mokrzycki Nathalie, Timmerman Philip
AstraZeneca R&D, Gothenburg, Sweden.
Janssen R&D, Beerse, Belgium.
Bioanalysis. 2019 Jun;11(13):1227-1231. doi: 10.4155/bio-2019-0139.
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.
在本会议报告中，我们总结了关于“数据完整性”研讨会的主要发现和信息。该研讨会与药品及保健品管理局合作，于2018年11月21日至23日在巴塞罗那举行的第11届欧洲生物分析论坛开放（EBF）研讨会上召开，旨在深入了解和认识监管机构对数据完整性的期望。研讨会强调了与软件开发人员合作以弥合行业数据完整性需求与当前系统软件功能之间差距的重要性。与会代表还认识到实施额外程序控制以降低使用不完全符合数据完整性要求的系统所带来风险的重要性。
