Pharmaceutical Audit Trail Blockchain-Based Microservice

Abstract

: 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.