Infrastructure Qualification and Compliance Services: Ensuring Continuous Compliance in a Dynamic Regulatory Landscape

As the 21st century progresses, regulatory scrutiny on IT infrastructure supporting GxP (Good Practice) critical applications in the Life Sciences sector has increased significantly. Organizations are challenged to manage their IT infrastructure efficiently while adhering to stringent regulatory standards. Stefanini provides industry-leading IT infrastructure control and compliance services, leveraging GAMP (Good Automated Manufacturing Practice) principles and enhancing them with best practices for comprehensive information systems (IS) compliance.

IT Infrastructure: The Backbone of GxP Compliance

IT infrastructure, including computer systems, hardware, layered software (excluding business applications), network components, and the associated personnel and processes, is crucial for regulatory significant activities. Regulatory bodies expect these systems to operate without faults and be continuously available, necessitating a planned qualification process and ongoing control.

Is your IT infrastructure ready to meet the stringent demands of regulatory compliance, ensuring the flawless operation of GxP critical systems and applications? How confident are you in the current qualification status of your IT infrastructure? Does it align with industry best practices and regulatory expectations for supporting life sciences operations? Do you have a strategic approach to qualifying and maintaining your IT infrastructure that not only meets regulatory requirements but also promotes operational excellence and cost efficiency?

Learn how our Infrastructure Qualification Services can strengthen your compliance strategy.

Our Comprehensive Services:

Compliance Assessments: We perform in-depth IT infrastructure compliance assessments to ensure alignment with industry best practices and regulatory standards, utilizing our proprietary tools for a thorough evaluation.
Sustainable Processes: Developing sustainable IT infrastructure qualification and control processes, we integrate Stefanini ’s risk-based approach with the client’s existing practices for long-lasting compliance.
Qualification Process: Implementing a detailed qualification process for both new and existing platforms ensures they meet regulatory standards while being cost-effective.
Ongoing Support: We provide services to help end users or their service providers maintain a controlled IT environment, ensuring ongoing regulatory compliance.
IT Quality Management System: Assisting organizations in establishing a robust IT Quality Management System (IT QMS) that covers all aspects of qualification and control, we create practical processes and detailed procedures or work instructions for a comprehensive approach to IT infrastructure compliance.

Why Choose Stefanini?

Regulatory Expertise: Stefanini’s services are rooted in a profound understanding of regulatory requirements and industry best practices.
Cost Efficiency: Our risk-based approach ensures clients achieve compliance without unnecessary costs, providing significant savings.
Ongoing Guidance: We offer not only initial qualification support but also ongoing guidance to keep your IT infrastructure compliant over time.
Tailored Services: Our services are tailored to meet your specific needs, ensuring a personalized and effective approach.
Comprehensive Solutions: Covering every aspect of quality and regulatory support, we provide a one-stop solution for all your needs.

Stefanini assists your Life Sciences organization in achieving and maintaining a state of compliance with our specialized IT infrastructure services. From initial assessments to IT QMS development, we ensure your IT infrastructure meets regulatory expectations efficiently and effectively.