Despite increasing digitalization, many life sciences organizations still face the challenge of transitioning from outdated, manual and paper-based processes to a fully digital, integrated compliance system.
NNIT’s Digital Compliance Transformation Advisory Service is tailored to facilitate this significant shift, ensuring organizations can realize the full potential of digital compliance.
Challenges Addressed:
- Technology and Data Integration: Overcoming the limitations of manually driven systems with low integration levels, leading to poor data quality and inefficient compliance reporting.
- Future-Proofing Processes: Updating processes and procedures to support the use of new technology effectively.
- Cloud Readiness and Security Concerns: Balancing the need for cost savings with the perceived business risks associated with cloud and SaaS solutions.
- Complex Compliance Achievements: Streamlining the validation of infrastructure, operational systems, and projects for audit and inspection readiness.
- Manual Approval Flows: Modernizing document management and approval processes based on industry best practices, moving away from paper-based systems.
- Organizational Change Management: Addressing industry conservatism and resistance to new technologies and practices.
Our Solution:
NNIT’s Digital Compliance Transformation Advisory Service guides your organization through every step of the complex transition:
- Get Started with Initial Assessment: Establishing the current 'as-is' state, identifying potential compliance gaps, and providing mitigative actions.
- Strategic Planning and Scope Definition: Collaborating closely with clients to define a vision, strategy, and the desired 'to-be' state, covering process, technological, and organizational aspects.
- Implementation and Quality Control: Initiating action implementation and adding quality controls to achieve the desired compliance level and audit readiness, with a focus on continuous improvement.
Benefits:
- Improved Compliance and Quality: Enhanced validation and test planning capabilities for faster, more accurate decision-making.
- Enhanced Validation Management and Control: Full traceability and audit readiness through an integrated Application Lifecycle Management System.
- Increased Operational Efficiency: Technological advancements driving process automation and operational excellence, freeing up resources for innovation.
- Streamlined Document Management: Efficient preparation and approval flows within an integrated Document Management System.
- Accelerated Business Processes: Faster test execution and reduced time-to-market through advanced Test Automation tools.
