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Our client service is
based on our core competency to integrate technology expertise
with GxP regulations. The core elements of our client service
are
providing compliance strategies
developing polices and program frameworks
validating systems and
providing systems integration services. The knowledge gained through our project
experience and technology expertise has helped us provide
effective and pragmatic solutions that exceed the FDA
expectations.
Our client services can be broadly
classified into these functional areas
Validation and Compliance Services
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21 CFR Part 11 Practice |
IT Infrastructure Qualification Practice |
| Our Part 11
portfolio encompasses corporate wide strategy to
risk management to design/validation of
individual applications. |
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| Our unique
knowledge of current IT technologies and
compliance enables us to provide an effective,
standards based IT network infrastructure
qualification program. |
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GMP/GLP/GCP Validation Practice |
Compliance Consulting &
Auditing Practice |
| We are the
technology validation experts. We validate
computerized applications utilized in
Laboratory, Manufacturing, Clinical and
Preclinical areas. |
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| We can
design and implement compliance frameworks,
policies and programs to meet all your GxP
needs. |
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Vendor Solutions
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We provide equipment / software vendors catering to the life
science market with 21 CFR Part 11 and validation services
to ensure their products stay relevant and compliant.
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Systems Integration
Business Process
Automation |
Plant Automation |
| We
accelerate the business processes of a life
science company by implementing applications
based on the robust Microsoft SharePoint and
.NET. |
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| We deliver
turnkey plant automation solutions using the
latest technologies in process automation. |
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Contact Us