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Client
Services
Validation
- Preparation and Execution of Validation Master Plans
- Validation Project Management
- Preparation and Execution of Validation Protocols
- Facility Qualification
- Utility Qualification
- Equipment Qualification
- Software Qualification
- Sterilization Cycle Development and Validation
- Process Validation
- FAT/SAT Testing
- CGMP Compliance and Optimization
- Assessment/Audits
- Process Scale-Up, Optimization and Production Plans
- Clean Room/HEPA/Laminar Flow Certification
- NSF Certified Services
- Program Management
- Design Services
- Clean Room
- Facility
- Laboratory
- Quality Assurance Services
- Evaluation of 21 CFR Part 11 (Electronic Records and Signatures) compliance
- Vendor and Quality System Auditing
- SOP development
- USP 797
- Calibration
- On-site Calibration
- Facility Calibration Program Management
- Lab Environmental Health and Safety
- OSHA Compliance Program
- Maintenance of Safety Equipment
- Hazardous Waste Management Program
- MSDS Management Program
- Support Services
- Project Management
- Troubleshooting, Repair, Maintenance
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