The shift from traditional on-premises software solutions to cloud-based SaaS models requires a new approach to validation and qualification in the life sciences sector.
NNIT’s Agile Cloud GxP Validation solution is designed to address this transition, focusing on the dual layers of cloud-based systems: the application layer for validation and the infrastructure layer for qualification.
Challenges Addressed:
- Transition to Cloud-Based Systems: Navigating the shift from on-premises to cloud solutions.
- Complex Software Lifecycle: Overcoming costly and complex updates associated with traditional software cycles.
- Quality Assurance in Cloud Provisioning: Ensuring high-quality standards in the provisioning of cloud infrastructure.
- Documentation and Compliance: Maintaining accurate records and compliance with regulatory standards in a cloud environment.
Our Solution:
NNIT’s Agile GxP Cloud Solution Factory provides a robust and efficient pathway for embracing cloud technologies. It allows your organization to confidently navigate the complexities of cloud validation and qualification, ensuring that your cloud solutions compliant, scalable and future proof:
- Qualified ADO Platform: Utilizing an advanced, qualified Azure DevOps (ADO) platform for efficient cloud provisioning with integrated governance processes.
- CSA Principles Integration: Embedding Computer Software Assurance (CSA) principles for ongoing qualification and compliance.
- Automated Documentation and Quality Control: Automating the creation and maintenance of qualification records and quality controls.
- Dedicated QA Application: Managing quality records and verifying that processes are conducted under strict control.
Benefits:
- Efficiency and Quality: Achieving high efficiency and quality through the use of the qualified ADO platform.
- Embedded Qualification Process: Ensuring that the qualification is an integral part of the provisioning process.
- Continuous Qualification: Enabling ongoing qualification in line with CSA principles.
- Scalability and Automation: Facilitating scalability and automation in cloud-based solutions.
