Compliance Transformation
Infosys' Compliance Transformation Solution (CTS) is targeted for life sciences companies, the Pharmaceutical, Biotech, Medical Device industry and CROs. The solution provides a single platform for managing regulatory compliance for life sciences companies 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
Benefits
- Provides a process-driven content management system 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