Computerized System Compliance & Validation Consulting Services for an Intelligent Pharma Factory

Driven by Industry 4.0, the pharmaceutical industry is facing unprecedented opportunities and challenges. It is urgent to implement digital transformation and intelligent upgrading and introduce advanced manufacturing design concepts to build a green manufacturing system.

The client, as a subsidiary of a large pharmaceutical group, planned to build an intelligent green factory. As part of this project, the "intelligent" concept of digitization, networking, continuity, and environmental protection would be introduced to its dedicated solid preparations workshop, to promote production and quality informatization, and build an intelligent manufacturing system.

Project Objective

• Comply with FDA cGMP and relevant regulatory standards.

• Meet ISPE GAMP5 requirements for computerized system compliance & validation.

Service Scope

• Computerized system compliance & validation consulting services for WMS&WCS, MES, EMS, SCADA and IT infrastructure.

• Validation master plan, risk assessment, process equipment qualification and warehousing system qualification, etc.

Customer Benefits

• Intelligent upgrading of the factory- a digital, intelligent and green modern pharmaceutical factory has been built.

• Better regulatory compliance – the manufacturing system runs smoothly following function design specifications and complying with FDA cGMP.

• Closed-loop management of the entire production process route – the cost savings, energy consumption and low-emission goals were achieved.