Computer System Validation
VTS provides computer system compliance solutions to FDA regulated pharmaceutical, medical devices manufacturing, and biotech companies. Our goal is to assure that the computer systems in regulated environment are operating in accordance with a company's policies and 21 CFR Part 11.
Computer System Validation is to provide documented evidence that a system performs its intended function and will continue to do so. VTS uses proved and recognized System Development Life Cycle (SDLC) methodology for computerized system validation.
VTS provides validation expertise in the areas of Enterprise Systems such as Manufacturing Execution Systems (MES), Enterprise Content Management (ECM), Materials/Enterprise Resource Planning (MRP/ERP), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Learning Management Systems (LMS), Sales Force Automation (SFA), Clinical Data Systems (CDS), and IT Infrastructures & Platforms.
Key deliverables of a VTS validation engagement include:
- Validation Plan
- User Requirements Specification
- Functional Requirements Specification
- System Design Specification
- Vendor Audit
- Master Test Plan
- Unit, Integration Test Plans
- Installation Qualification Protocols
- Operational Qualification Protocols
- Performance Qualification Protocols
- User Acceptance Test Protocols
- Training Plan
- Traceability Matrix
- SOP Audit
- Test Summary Reports
- Validation Summary Report