QA and QMS
Internal or external systems suppliers (IT Organizations) in the Life Sciences industry must be governed by SDLC-centered and Compliance-focused Quality Management Systems. According to GAMP5, the expected QMS should define:
- The process being followed in order to deliver and support the system
- Responsibilities, including clear separation of authority between Quality Assurance and other groups
- Deliverables and Documentation
- Planned reviews of the QMS and internal audits, as a part of continuous improvement of QMS and its use.