Quality assurance
We can assist you various operational quality assurance tasks. We provide tailor-made services to efficiently support the following quality operations:
- Implementing the latest industry standards and trends: ICHQ8/Q9/Q10, FDA Guidance for Industry
- Change control, deviations, CAPA, complaints and OOS analysis and remediation
- Risks analysis
- Root cause analysis
- Periodic review
- GMP documentation streamlining (SOP, Batch record,...)
- Support with respect to regulatory events such as recalls or warning letters
As lead or support, we provide support in Audit:
- Quality system
- Computerized System Auditing
- 21 CFR part 11 Compliance
