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Validation & Technical Services Integrated, Inc.
Validation & Technical Services Integrated, Inc. (VTSI) is a full service Validation, GMP Compliance, Engineering, Equipment Design/Supply Consulting firm dedicated to serve the FDA regulated Pharmaceutical, Biotechnology and In-vitro Diagnostic industries. We offer assistance in Facilities Management, Validation, Operations Support, Facility Engineering and provide turnkey services or secondary services that is both aggressive and practical without compromising quality. We also provide Architectural design, procurement, planning, engineering, construction, project management, commissioning, system integration, and operation optimization services. Equipment Design and Supply to both FDA regulated and non-regulated industries is eventually an integration of our strong background in Validation & Technical Services Integrated Inc. Our design principles follow both Good Engineering Practice (GEP) and Good Manufacturing Practice (GMP).
Regulatory and Compliance Services
- Explanation of FDA regulations and expectations
- FDA consent decree issues
- Third party review services
- FDA Certification Audits
- Risk Management Review and Risk Assessment Review
Quality Systems and Validation Services
- Quality system evaluation and development
- Quality assurance oversight of contract services
- Document system development and review
- Calibration and metrology program
- Computer systems and software assessment and validation program
Engineering Services
- Technology analysis
- Process design specification
- Equipment specification, selection, costing, and placement
- Conceptual facility design
- Facility, equipment, and process design review
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