Case Study
Field: Pharma/Biotech
Background
Engineering project management company
Challenges
- Regulatory Engineering consultancy
- Quality Assurance services
- Process Engineering
- GMP services and guidance
- GEP services and guidance
- Validation protocol establishment
- Equipment and system Validations
- Control systems and system HMIs 21 CFR part 11 Validation
- Monitoring system CFR part 11 Validation
- Engineering and Technical documentation