Nutech Information Systems understands the challenges FDA regulated companies face in keeping up-to-date with the on-going changes in the industry, implementing new technologies, and maintaining compliant systems. Our Validation practice addresses the industry need to establish documented evidence that provides a high degree of assurance that computerized systems will consistently perform as intended in their operational environment according to predetermined specifications and quality attributes. We use a proven consultative and collaborative approach. Using the unique combination of hands-on System Development Life Cycle (SDLC) management and Computer Systems Validation (CSV) experience, our Validation team works closely with you in determining and processing your validation needs.

We take the time to understand your strategic business needs and adjust our validation services to meet them in accordance with current regulations. We value long-term relationships, and therefore, we want you to see NUTECH INFORMATION SYSTEMS as a trusted and valued partner.

Our passion is to deliver exceptional customer service as we work to complete each project on time and within budget. Our Validation experts have over 10 years of experience working closely with system implementation teams and software solution vendors to ensure compliance with 21 CFR regulations and the completion of the validation process.

NUTECH INFORMATION SYSTEMS has a proven track record and is prepared to assist you in your validation efforts by providing full validation lifecycle services -- ranging from turnkey validation management solutions to the execution of specific validation tasks. We want to partner with you and your team by offering you the following services:

• Validation Strategic Planning
• Validation Project Services
• Validation Documentation
• Specialized Validation Training

Validation Strategic Planning

Allow NUTECH INFORMATION SYSTEMS to partner with you in defining an approach for implementing and supporting your validation efforts company-wide by providing:

Validation Master Planning Contingency Planning Vendor Audits

SOP Definition and Development SDLC Methodology Definition and Development Support & Maintenance Planning

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Validation Project Services

NUTECH INFORMATION SYSTEMS understands that each project is different and must be approached using open communication with our clients. NUTECH INFORMATION SYSTEMS works in partnership with our clients to ensure a quality and reliable product is delivered, meeting the FDA regulations and guidelines.

Project Management Services Risk / Gap Analysis Requirements Gathering 21 CFR Part 11 Assessments

CSV Implementation Planning System Retirement Planning Protocol Execution Vendor Audits

Validation Documentation

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Validation Plan Training Plan Functional Requirements IQ/OQ Requirements Deviation Log and controls Validation Summary Report Training Guides

Testing Plan User Requirements SDLC Documentation PQ Test Protocols Trace ability Matrix Validation SOPs User Guides

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Specialized Validation Training

NUTECH INFORMATION SYSTEMS offers a variety of training services that can be customized to fit your company's specific needs and methodology. These training sessions can be prepared to target a variety of areas within your company, including Operations (End Users), Information Technology, Quality Assurance, Management, and the general audience.

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