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Overview
Compliance NT is dedicated to providing a complete range of validation, quality assurance, and regulatory compliance services to the pharmaceutical, biotechnology and medical devices industries.

We focus on and serve the needs of our clients by accelerating customer success and delivering reliable, well managed, and organized services. Our commitment to provide superior quality time based products, well educated and knowledgeable staff, and our focus on our mission, are the factors that make Compliance NT standout in today’s aggressive marketplace.

Compliance NT is directed by a management team that is backed by more than a 75 years of validation and regulatory experience in both the operating and consulting industries. Our specialized technical staff provides customers with expertise in all aspects of validation.

Services Offered
Compliance NT provides the expertise necessary to develop and execute the following compliance documentation.

Commissioning
Gap Analysis
Standard Operating Procedures
Master Plans
Factory Acceptance Tests
Site Acceptance Test
21 CFR Part 11 Assessment
Installation Qualification
   o Equipment
   o Utilities
   o Computer Systems (PLC, SLC, DDC, PC, SCADA, etc.)
Operational Qualification
   o Equipment
   o Utilities
   o Computer Systems (PLC, SLC, DDC, PC, etc.)
Performance Qualification
   o Equipment
   o Utilities
   o Computer Software
Process Qualification
Compliance Life Cycle Documentation
   o Computer Software Validation Plan
   o User Requirements
   o Functional Requirement Specifications
   o Detailed Design Specifications
Cleaning Validation

 

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