Welcome to the Electronic Batch confluence space.

The objective of this application:

• To demonstrate Pharmaceuticals Good Manufacturing Practices (GMP) , SA&D has subscribed to the ICH Q7 standards which clearly specifies procedures to be followed in order to release batches, gathering data from various sources of information (raw materials, packaging, process conditions...).
• The batch recording is mandatory in case of audit and / or customer request and we must guarantee data integrity without the risk of human errors. However, the current manual process for data collection and validation is very difficult to maintain. 
• This initiative aims to automate data collection processes for SA&D sites linked to Pharma Market, based on existing data collection architectures (Data Lake, Startek) hence reducing as much as possible manual inputs, minimizing error risks and maximizing time. 
• The result will be a webapp reporting platform
• Project scope on sites:

• Torrelavega
• Dombasle 
• Map Ta Phut

Here are the pages available for the project :

• Documentation (in /Documentation)

  • Electronic Batch - 1 - Management: Project presentation, Criticality, Referees, Knowledge management

  • Electronic Batch - 2 - Functional: Description, Stakeholders, Constraints

  • Electronic Batch - 3 - Technical - Data Pipeline: Data Architecture Flow, Steps description

  • Electronic Batch - 4 - Technical - Analytics Pipeline: Data Architecture Flow, Steps description

  • Electronic Batch - 5 - Operational: Procedures, Scheduling, Monitoring, Error Handling

  • Electronic Batch - 6 - Maintenance: On-boarding

• Maintenance Roadmap : Electronic Batch - Roadmap