GMP Quality Systems
We create compliant and effective paths of interaction between the elements of the FDA quality system model, and your organization.
- Batch record design and review
- Change control system
- SOPs, protocols, logbooks
- Audit programs; Internal, CMOs
- In-process controls
- CAPA System
- Back-logs
Six Sigma
Six Sigma provides organizations tools to improve the capability of their current GMP processes. As a result, there is a decrease in process variation (deviations) and an increase in performance, building highly effective GMP systems.
- Internal Benchmarking
- Business measures
- DMAIC Methodology
- Root cause analysis
- Gap Analysis