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Compliance transformation

Infosys Compliance Transformation Solution (CTS) is targeted for the pharmaceutical, biotech, medical device industry, and CROs. The solution provides a single platform for managing regulatory compliance by automating compliance processes and ensuring accountability of relevant people, process, and technology compliance to business functions.

Our solution addresses:

  • Compliance with regulations and standards such as GxP, 21 CFR Part 11
  • Governance, control and execution of people, processes, and technology
  • Reducing risk of compliance breach, audit observations, and findings

Key methodologies / frameworks

  • IT system compliance: Manages all the IT systems having regulatory compliance or corporate quality implications
  • Process compliance: Defines self-contained critical business processes and provides the platform for people compliance with these processes
  • People compliance: Grants / restricts access to corporate applications based on training needs
  • Regulatory e-submission: Integrates with content management systems, repositories, and XML technology standards
  • Software code and test scripts reusability: Registers software code, associated test scripts, and test plans


  • Provides a process-driven content management system, which is tightly integrated with activity monitoring tool and metrics to enhance both compliance and efficiency
  • CTS backed with consulting services such as assessment, design and execution, and reporting, which significantly reduces cost of compliance
  • Customized processes frameworks such as e-submissions, IT system compliance, CSV, and GxP already available for quick ROI
  • Web-based, flexible, and modular solution based on multi-tier architecture allows easy integration with client's environment, resulting in low implementation costs
Regulatory Compliance Transformation Solution

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