Computer System Validation (CSV) is a critical element of pharmaceutical validation. CSV is a process used to ensure that computer-based systems will produce information or data that meet a set of pre-defined requirements. If a computer system meets these specific requirements, it can be assumed that it is consistently performing as per your intended purpose.
- Computer System Validation
- Why Do We Need Computer System Validation?
- CSV regulatory requirements
- Computer System Validation Documentation
- CSV process
- Mapping out a User Requirement
- Writing a Validation Master Plan
- Test cases – including installation, operational and performance qualification (IQ/OQ/PQ)
- Validation Protocol
- Validation Report
Case Study: Protocol Writing