Even with robust quality systems governing your analytical laboratory and a strong data integrity (DI) program in place, you may still be nervous about preparing for a regulatory inspection. What will the inspectors want to know? What will they ask? Is your team prepared?
- How DI plays a role in the inspection
- How to understand and answer the inspector’s questions
- How to understand the impact of poor analytical decisions
- How to use systems that can help demonstrate DI and regulatory compliance
- How to use technical controls to enforce operating procedures