Innovative computer system validation
The automated production environment of your pharmaceutical company is controlled and monitored by a computer system and/or PLC. Therefore, this computer system has to be 100 per cent reliable. And that’s where you can rely on Advipro’s expertise.
-
“The validation process performed by our engineers provides documented proof that the system meets the predefined specifications for the entire life cycle of the system.”Brendt – Project Manager
The ultimate guide for taking a thorough and structured approach to a CSV is undoubtedly GAMP5©. Those guidelines describe procedures and principles by which you can demonstrate that your pharmaceutical products are continuously of the highest quality. Only possible if you validate all stages in the production process. Moreover, the guidelines apply to any computer system that generates data that you use to make quality decisions or report to FDA.
Computer system validation - Advipro @ your service
- GAMP5©: important guidelines for companies involved in the development and/or implementation of automated systems - companies that follow the GAMP5© guidelines can ensure the quality of their automated systems
- Risk control & quality management
- Determining software category (GAMP5©)
- Defining the relevant validation steps & applying them in a risk-based manner
- Risk analysis to determine which parts of a system need to be validated and which do not
- Computer system life-cycle management
- Data integrity
