HDI, Inc.











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Consulting & Contracting


contracting

One of our greatest strengths is taking your production requirements and business objectives and recommend one or more approaches to a complete auxiliary system and/or plant design.

We work with you through the design, engineering, manufacturing and installation phases to meet your unique application needs and stay in constant contact for a strong support relationship in the future.

We offer Project Management Services: Startups, Product Transfer, Process Validation and Documentation, In-House Training and we can help you Move to Latin America.

HDI can validate new and current systems, recommendations, implementation of corrective and preventive actions for general improvement. Current activities include: SOP revisions, Risk Assessment, User Requirements development, Functional Design Specification development, Installation Qualification, Operational Qualification, Performance Qualification, Test Plan Protocols creation, their executions and summary report in compliance with the Food and Drug Administration regulations. Assuring Validation Documentation falls under strict cGMP’s compliance. Assessing computerized equipment for 21 CFR Part 11 compliance.