Pharmaceutical-Technology-MES-solution

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  • 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 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 vSANvCenter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。



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