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 |
 |
|