What are GAMP 5 guidelines?
GAMP is a risk-based framework for validating and controlling digital healthcare and pharmaceutical systems. The International Society for Pharmaceutical Engineering (ISPE) released the framework back in 1994, and it’s currently in its fifth version. The GAMP framework offers common automation terminologies as well as best practices. It also contains resources for documentation, procedures, testing, and user requirements.
GAMP 5 guiding principles help organizations:
- Understand the product and process clearly
- Use a quality management system (QoS) to manage the system lifecycle
- Scale all lifecycle activities
- Verify that they’re using a science-based approach to risk management
- Integrate suppliers throughout the system