Successfully applied GxP compliant software development principles, including: Risk Management and Change Control and Validation
Implemented software development methodologies with a strong emphasis on GxP regulations, particularly adhering to: 21 CFR Part 11, to Ensured that electronic records and signatures met regulatory requirements.
Deployed Industrial Data Centers utilizing Hyper Converged Infrastructure (HCI) to enhance scalability and performance.
Implemented VMware vSphere vSAN and vCenter for virtualization management.Collaborated effectively as part of a large, multi-disciplinary team, successfully completing full project life-cycle implementations from planning to execution.
Designed, configured, and implemented network architecture tailored for industrial controls and SCADA environments, ensuring reliability and performance.
Managed the operation and maintenance of the bastion host for the RIS-ACA Qizhi Access Control Audit System, ensuring secure access and compliance.
Managed the operation and maintenance of the bastion host for the RIS-ACA Qizhi Access Control Audit System, ensuring secure access and compliance.
Deployed a Data Center integrated with a Pharmacy Industrial Manufacturing Executive System (MES) to streamline operations and enhance productivity.
Implemented both Relational Database (RDB) and Real-Time Database (RTDB) systems to support data management and real-time processing needs.
Developed role-based optimization strategies for each life cycle stage, resulting in faster time to results and improved efficiency.
Deployed value-based applications that facilitated growth in both batch and discrete processing while ensuring adherence to regulatory compliance guidelines.
Implemented a comprehensive Electronic Batch Recording (EBR) system to automatically track all production-relevant resources, including materials, equipment, and personnel.
Deployed a firewall rule base based on application ports to enhance security and control over network traffic.
成功应用符合GxP标准的软件开发原则,包括:风险管理、变更控制和验证。
实施了以GxP法规为重点的软件开发方法,特别遵循:21 CFR 第11部分,确保电子记录和签名符合监管要求。
部署了利用超融合基础设施(HCI)的工业数据中心,以增强可扩展性和性能。
实施了VMware vSphere vSAN和vCenter进行虚拟化管理。
作为大型多学科团队的一部分有效协作,成功完成了从规划到执行的完整项目生命周期实施。
设计、配置并实施了针对工业控制和SCADA环境的网络架构,确保可靠性和性能。
管理RIS-ACA Qizhi访问控制审计系统的堡垒主机的操作和维护,确保安全访问和合规性。
部署了与药品工业制造执行系统(MES)集成的数据中心,以简化操作并提高生产力。
实施了关系数据库(RDB)和实时数据库(RTDB)系统,以支持数据管理和实时处理需求。
为每个生命周期阶段开发了基于角色的优化策略,从而实现更快的结果时间和提高效率。
部署了基于价值的应用程序,促进批处理和离散处理的增长,同时确保遵守监管合规指南。
实施了全面的电子批记录(EBR)系统,以自动跟踪所有与生产相关的资源,包括材料、设备和人员。
部署了基于应用程序端口的防火墙规则库,以增强安全性和对网络流量的控制。