以區塊鏈建構GMP資料完整性框架

近年FDA對各國藥廠所發出的警告信中，數據完整性的缺失逐年升高，在2017年比率高達68%，這讓各國藥廠對數據完整性的問題更加重視。在目前各藥廠GMP (Good Manufacturing Practice, 優良製造標準) 電子數據大部分仍是採主從式架構進行保存，並以備份軟體或異地備援方式進行數據保護。在電子數據保存方面算是已進入平穩期，但要驗證數據符合FDA (Food and Drug Administration, 食品藥品監督管理局) 的數據完整性規範，目前仍需要進行優化改善。本研究採用「理論建構貢獻」研究法進行說明，藉由文獻探討的方式，描述如何透過區塊鏈的五大特性：去中心化、匿名性、不可竄改性、追蹤性及加密性與IPFS（InterPlanetary File System, 星際檔案系統）的Merkle DAG (Merkle directed acyclic graph, 默克爾有向無環圖) 技術進行結合，並透過智能合約進行用戶的權限與數據的管控，符合FDA數據完整性ALCOA規範需求。其研究貢獻為將構建出透過區塊鏈、智能合約與IPFS的特性，以符合FDA數據完整性規範的流程框架與虛擬碼，期望透過具前瞻性的創新技術與商務實務面的解決方案，來解決當前所遇到的問題。

關鍵字

區塊鏈；智能合約； IPFS ；資料完整性

並列摘要

In recent years, the FDA issued warning letters to pharmaceutical companies in various countries indicating the lack of data integrity increases every year. In 2017, a total 68 percent of them drew attentions to the issue of data integrity for many pharmaceutical companies. At present, most of the GMP electronic data in pharmaceutical companies are still stored in client–server fashions, and the data is protected using backup software or remote backup. However, the data storing mechanism has reached the limit and required optimization to verify that the data complies with FDA data integrity specifications. This paper uses "Current Dimensions for Theoretical Contribution" research method, based on the literature review, to describe how to use five characteristics of the blockchain: decentralization, anonymous, incorruptible, trackable and encrypted to work with the IPFS Merkle DAG technology. The research uses Smart Contract technology to assure the user's authority and data accessibility in order to fulfil the FDA's ALCOA specification requirements. The contribution of this study is to build a process framework based on blockchain technologies and pseudo code that conforms to the FDA's Data Integrity Specification. It’s expected to apply the proposed innovative framework to practical business applications.