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Outsourcing

MITI recognizes the importance of organization’s need to environmental, occupational health & safety compliance. We provide cost-effective regulatory solutions to offset hefty fines for non-compliances. Our solutions address pharmaceutical/medical equipment industry and government regulations, including US FDA GxPs and 21 CFR Part 11, as well as computer system and software testing for a variety of industries following SDLC.

We offer complete services of surveying your Company’s operations, evaluate results, conduct computer validation and offer compliance solutions to address non-compliance challenges.

MITI’s Life Sciences Quality & Compliance services are specifically designed to mitigate risk.

You can benefit from:

Knowledgeable and team-oriented project managers and analysts
An ability to approach virtually any technology with expert personnel
A "brain trust" type of environment that can assist with almost any question in the realm of computer validation, Part 11, and computer system testing
A customized approach to meet individual client requirements
Clear, well-organized, and defensible SOPs, validation reports, testing reports and other documentation to meet the most stringent regulatory requirements.

MITI's Services Cover:

Compliance Plan Development
Awareness Training
21 CFR Part 11 Interpretation
System Inventory Development
Business and Regulatory Risk Assessment
Advanced Training
System Assessments
System Compliance Strategy
Remediation Planning
Execution of Technical and Procedural Remediation Activities
Implementation of Compliant Systems



For more details, Please email: info@mitiweb.com or send an enquiry or
call us on the nearest location for an Millennium Infotech representative to contact you.
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