Computer System Validation is to provide documented evidence that a system performs its intended function and will continue to do so. TriTech uses proved and recognized System Development Life Cycle (SDLC) methodology for computerized system validation.
TriTech 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.
TriTech provides validation expertise in the areas of Enterprise Systems such as Manufacturing Execution Systems (MES), Clinical Data Systems (CDS), Enterprise Content Management (ECM), Quality Management Systems (QMS), Materials/Enterprise Resource Planning (MRP/ERP), Product Lifecycle Management (PLM), Learning Management Systems (LMS), Sales Force Automation (SFA), and IT Infrastructures & Platforms.
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