基于区块链的医药审计跟踪微服务

S. Loss, Lucas Cardoso, N. Cacho, Frederico Lopes
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引用次数: 0

摘要

巴西的药品生产要求其流程按照监督机构:国家卫生监督局(葡萄牙语为ANVISA)制定的规则进行。ANVISA要求所有制药系统保证所有产品信息的完整性、安全性和可追溯性。这些规则确保制造的产品不会对消费者构成风险。制药业面临的困难之一是提供证据证明生产程序是在基于这些规则的内部规定下进行的。一种方法是使用审计跟踪。它可以使用计算机系统自动存储这些信息以记录所有动作。然而,仅仅使用审计跟踪并不能保证数据的安全性;确保所有信息都是不可变的是必要的。因此,在本文中,我们提出了一种基于区块链的审计跟踪微服务。该技术将所有交易存储在链接和加密的块中,以避免非法修改。它还保证了数据的不变性、安全性和可追溯性。此外,我们提出了一个案例研究来评估使用Nuplam(食品和药品研究中心)综合管理系统的拟议方法。在本案例研究中进行了压力测试,以评估所提出的解决方案在制药系统中的适用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmaceutical Audit Trail Blockchain-Based Microservice
: Pharmaceutical manufacturing in Brazil requires that its processes are carried out by following rules defined by a supervisory body: the National Health Surveillance Agency (ANVISA, in Portuguese). ANVISA requires that all pharmaceutical systems guarantee all product information’s integrity, security, and traceability. These rules ensure that the manufactured products do not pose a risk to their consumers. One of the difficulties for pharmaceutical industries is to provide evidence that production procedures were carried out under internal regulations based on these rules. One way to do this is by using an audit trail. It can store this information automatically using a computer system to record all actions. However, only using audit trails does not guarantee data security; ensuring that all information is immutable is necessary. Therefore, in this paper, we propose an audit trail blockchain-based microservice. This technology stores all transactions in linked and encrypted blocks to avoid illegal modifications. It also guarantees data immutability, security, and traceability. In addition, we present a case study to evaluate the proposed approach using Nuplam’s (Nucleus for Research in Food and Medicines) Integrated Management Systems. A stress test was performed in this case study to evaluate the applicability of the proposed solution in pharmaceutical systems.
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