Hari Om Tatsat Technologies

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Services for US FDA Title 21 of CFR Part 11 (21CFR11)
We have requisite experience in dealing with the Regulators and the Management of the Organizations for formation of IT Governance and Information Security Policies / Standards. This expertise of understanding the Management Intent and Interpretation of Regulatory requirements helps us in giving sound advise to our clients and assist them to implement, achieve & maintain Compliance to US FDA 21CFR11 and achieve business benefits.

Our technical skills (in Technology and Pharma / Medical Equipments) helps us in providing requisite consultation and implementaion services for Compliance to 21CFR11 Regulations.

The Compliance related services that we offer in the area of 21CFR Part 11 are as listed under:

Our Services / Solutions for US FDA 21 CFR Part 11
Perform Computer Software Validation (CSV)
Conduct Gap Assesment
Design SOPs & Policies
Develop Testing Framework
Build Test cases
Traing on 21CFR11 Regulatory needs
Assistance to adopt SDLC model / Risk Management Framework
Give Advisory Services
Our Services / Solutions for US FDA 21 CFR Part 11
Handhold the implementation
Review / Audit the Assessments
Review Strategies
Project Management / Handhold for plugging Gaps
Manage Documentation
Assist in evaluation of Tools; Solutions & Vendors
Guidance on how to do Self Audits for continuous improvement
Implement, achieve & maintain Data Security

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