Overview: Integrated Qualification and Validation:Good Practice Guide from ECA
- Development of ECA´s Integration and Validation guideline
- Main content
- Comparision to other qualification guides
How suppliers work: Good Engineering Practice in Qualification
- Basic Engineering Workflows (CD, BD, DD – EPCMQ Projects)
- Process-, Equipment Engineers and more (the full picture)
- Key Documents in Engineering Processes
- FAT, SAT and Commissioning
- How a supplier can support qualification
- Typical pitfalls?
Cooperation between customers and suppliers on Integrated Qualification and Validation
- Importance of Project Quality Plan (PQP) as upfront clarification document
- Agreement of scope of supply and services – task for both contractual partners
- Technical documentation, Test documentation and execution - the effect of work-shops for common understanding and agreement
- Importance of Qualification Project Management - Collaboration spirit as key success factor
ECA Q&V Guide and tools: Risk-based qualification from URS to PQ
- Critical Aspects Risk Assessment (CARA) and its 3 steps
- Interface between Product and process requirements (PPURS) and URS
- CARA and the “red thread” of user requirements
- Support C&Q tools: Use of Test Matrix (TM) and Requirements Traceability Matrix (RTM) from DQ to PQ
ECA Q&V Case Study: Fast and effective project execution with suppliers
- International standard, common language with suppliers
- Using the best ideas in our company
- Categories of equipment: benefit during qualification
- What would we expect from our suppliers?
- Integrated Qualification and Validation from a pharma perspective