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Aguila Designers and Consultants Pvt Ltd sell "CONSULTANCY - COMPUTER SYSTEM VALIDATION / TRAININGS / REGULATORY AFFAIRS"

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基本信息

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子类别与细分类别

交易类型

出售

服务名称

CONSULTANCY - COMPUTER SYSTEM VALIDATION / TRAININGS / REGULATORY AFFAIRS

规格参数

  • 原产国: 多个供应国(视具体供应商而定)
  • 认证标准: 符合以下标准:21 CFR Part 11
  • 用途: 用于制药生产、加工与包装作业
  • 电源要求: 不适用——工程/咨询服务,无实体设备用电需求

其他信息

补充描述:

This consultancy covers project management with computer system validation and full documentation (GAMP 5, 21 CFR Part 11, Annex 11), spanning SAP and other ERP platforms, quality management, document management, stability management, artwork management, laboratory information management, training management, electronic archival and regulatory submission systems, vendor qualification workflows, PLC/SCADA evaluation, data integrity remediation, pharmacovigilance and clinical data management software, and regulatory information management systems, complemented by onsite and offsite training in quality management, computer system validation and data integrity.
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