Validation Systems
Validation Systems Incorporated (VSI) is a full-service validation contractor and laboratory testing provider serving the pharmaceutical, biotechnology, and medical device industries since 1990. Owned and operated by validation and laboratory professionals, VSI offers a wide array of validation and laboratory services, including validation support, laboratory testing, quality system development, and consulting. The company is registered with the FDA and its laboratory is ISO certified, emphasizing its commitment to quality and regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Validation Systems
Palo Alto, California, United States
Products
Validation & Technical Services
Comprehensive contract validation and technical services for biotech, pharmaceutical, and medical device industries, encompassing project management, facility qualification, and system validation.
Facility Utility System and Equipment Validations
Comprehensive qualification and validation services for utility systems and manufacturing equipment.
Validation Master Plans/Risk-based Strategies
Development of Validation Master Plans and tailored risk-based compliance strategies.
Project Management and Project Plans
Contract project management and project plan development for large or small scale validation projects.
Risk Assessment and Mitigation Strategies
Risk assessment services and development of mitigation strategies for facilities, utilities, and processes.
Design Review
Engineering and system design review services for validation and compliance.
Validation & Technical Services
Comprehensive contract validation and technical services for biotech, pharmaceutical, and medical device industries, encompassing project management, facility qualification, and system validation.
Facility Utility System and Equipment Validations
Comprehensive qualification and validation services for utility systems and manufacturing equipment.
Validation Master Plans/Risk-based Strategies
Development of Validation Master Plans and tailored risk-based compliance strategies.
Project Management and Project Plans
Contract project management and project plan development for large or small scale validation projects.
Risk Assessment and Mitigation Strategies
Risk assessment services and development of mitigation strategies for facilities, utilities, and processes.
Design Review
Engineering and system design review services for validation and compliance.
Services
Contract validation support including project management, design review, validation master plans, construction qualification, facility and equipment validation, computer system validation, process and cleaning validation, SOP and preventive maintenance procedure writing.
Development of Quality Manuals and customized SOPs, gap analyses, internal/external audits, and quality system procedure writing to support regulatory compliance and operational control.
Independent microbiological and chemical testing services including environmental monitoring, compressed gas sampling and analysis, water sampling and analysis, microbiological assays and method validation, and performance qualification testing.
Contract validation support including project management, design review, validation master plans, construction qualification, facility and equipment validation, computer system validation, process and cleaning validation, SOP and preventive maintenance procedure writing.
Development of Quality Manuals and customized SOPs, gap analyses, internal/external audits, and quality system procedure writing to support regulatory compliance and operational control.
Independent microbiological and chemical testing services including environmental monitoring, compressed gas sampling and analysis, water sampling and analysis, microbiological assays and method validation, and performance qualification testing.
Expertise Areas
- Validation and qualification services (IQ/OQ/PQ)
- Quality system development and regulatory compliance
- Microbiological and chemical laboratory testing
- Environmental monitoring and cleanroom qualification
Key Technologies
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP) compliance
- ISO quality management standards
- SDLC-based system validation
News & Updates
VSI announced the launch of their all-new website to provide easier access to information about their company and services.
VSI announced the launch of their all-new website to provide easier access to information about their company and services.