As the life sciences industry evolves, the need for innovative and streamlined approaches in software validation has become evident.
The Computer Software Assurance (CSA) model is an answer to this need, offering a modern alternative to the traditional Computer System Validation (CSV) methodology. Focusing on critical thinking over extensive documentation, CSA provides a more flexible and agile approach for ensuring that the software is not a threat to patient safety or product quality.
Challenges Addressed:
- Over-Reliance on Documentation: Moving away from the documentation-heavy approach of CSV.
- Need for Agile and Flexible Processes: Adapting to a rapidly changing technological landscape in Life Sciences.
- Incorporating Innovative Technologies: Embracing automation and new technologies in compliance processes.
Our Solution:
NNIT’s Computer Software Assurance service modernizes the approach to software validation in the Life Sciences industry, aligning contemporary needs for agility, quality, and efficiency:
- Advisory Services: Evaluating your current quality system and recommending improvements.
- CSA Framework Implementation: A complete CSA framework tailored to your organization's needs, including identifying software's intended use, conducting risk-based analysis, determining assurance activities, and establishing appropriate records.
- Digital Validation Execution: Conducting thorough CSA-based digital validation activities.
- Training and organizational change management.
Benefits:
- Enhanced Quality and Risk Mitigation: Achieving better quality outcomes with fewer resources.
- Increased Flexibility and Agility: Adapting more quickly to changes and new requirements.
- Reduced Documentation Burden: Shifting focus from extensive documentation to critical evaluation and assurance.
- Innovation-Friendly Environment: Paving the way for the adoption of cutting-edge technologies.
- Efficient Integration and Delivery: Streamlining processes to reverse the traditional 80/20 documentation-to-testing ratio.
- Organization-Wide Preparation: Assessing efficiency gains, cost savings, reevaluating IT quality processes, identifying test systems, and integrating business process owners in the software assurance process.
