Research on intelligent management of the data lifecycle for non-computerized instruments
10.19778/j.chp.2025.03.003
- VernacularTitle:非计算机化仪器数据生命周期智能管理研究
- Author:
Jingyan LI
1
;
Chao LIN
1
;
Jia WANG
1
Author Information
1. 无锡药明生物技术股份有限公司,江苏无锡 214000
- Publication Type:Journal Article
- Keywords:
data integrity;
ALCOA+principle;
pharmaceutical industry 4.0;
GxP regulations
- From:
Drug Standards of China
2025;26(3):251-254
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study addresses the challenges of data governance for non-computerized instruments in the context of pharmaceutical industry 4.0,proposing an intelligent transformation solution to overcome traditional data management bottlenecks.Methods and Results:By constructing a three-tier technical framework"net-worked architecture,highly compatible connectivity,and tamper-proof conversion":USB middleware is deployed to enable real-time data transmission from multiple instruments.Algorithms convert editable formats into non-editable files compliant with FDA 21 CFR Part 11 in real time;an automated backup system ensures data redundancy.Conclusion:Key innovations include a non-invasive transformation mode and an networked layout,offering a cost-effective pathway for upgrading traditional instruments to meet GxP standards.This research bridges the technical gap in data integrity management for non-computerized systems,ensuring regulatory compliance and operational efficiency.
