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
- Packaging Validation
- Shipping Validation
- CGMP Compliance and Optimization
- Assessment/Audits
- Process Scale-Up, Optimization and Production Plans
- Design and Commissioning Services
- Clean Room
- Facility
- Laboratory
- Design Qualification
- CGMP Compliance and Optimization
- Construction Management/Client Agent Services
- GxP Training
- Quality Assurance Services
- Evaluation of 21 CFR Part 11 (Electronic Records and Signatures) compliance
- Vendor and Quality System Auditing
- SOP Development
- Training
- Gap Analysis
- Impact Assessments
- Vendor, Supplier and Quality System Auditing
- Clean Room/HEPA/Laminar Flow Certification
- Program Management
- HEPA Filter Certification
- Airflow Velocity and Volume Testing
- Differential Pressure
- Visual Airflow Characterization
- Viable Surface and Air Sampling
- Non-Viable Air Sampling
- Routine Monitoring Services
- USP 797
- USP 797 Compliance Solutions Brochure
- Quality System Development
- Pharmacy Testing and Certification- Annual, Semi-annual, and Routine Testing
- Personnel Testing (Gloved Fingertip/Media Fill)
- Staff Training
- Pharmacy Design Assessment
- Gap Analysis
- Calibration
- On-site Calibration
- Facility Calibration Program Management
- Support Services
- GxP and Compliance Training
- Quality Assurance Related Services
- Equipment Repair and Maintenance
- Lab Environmental Health and Safety Including Chemical, Biological and Radiation Safety,
- Project Management
Click here to download a brochure detailing Quality Solutions' services.