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Transition to Computer System Assurance
Shweta Mohan Kulkarni Associate General Manager - Apps & SI for Life Sciences | June 28, 2021

Life Science Industry, Regulations, and Methodology

Life Science Industry like Healthcare is known to be a regulated industry and is always in the limelight due to strict regulations applied by regulatory bodies across geographies. While the regulations appear cumbersome, they are required to be complied to ensure Patient Safety, Product Quality, and Efficacy, leading to increased additional cost and time on developmental activities for pharma companies.

Over the years, the traditional Waterfall model has proved the most suited approach for validating systems in line with strict regulations. This came with rather heavy documentation that consumed a lot of time and effort. However, with the increase in the length and breadth of technology and its advancements, the aspect of being cost-effective without deviating from the regulatory framework has been repeatedly discussed. Thus, the need to transition from the traditional concepts of Computer System Validation (CSV) to Computer System Assurance (CSA) with the intent to improve Quality, reduce Validation cost and time, decrease testing issues, and most importantly, to deliver “Value” faster.

What is CSA?

The pivotal point for CSA is the Risk-Based Approach, which employs critical thinking and is based on software’s impact on patient safety, product quality, and system integrity. This approach focuses less on compliance, allowing more time and resources to be spent on improving Quality, Patient Safety, and implementing automated solutions and new technologies. Hence there is an urgent need for a mindset shift for Pharma companies. Similarly, Audit Inspection will now focus on ensuring that the right level of testing is performed for higher-risk activities while spending substantially less time documenting.

For CSA, the pivotal point is based on a risk-based approach using critical thinking, based on the software’s impact to patient safety, impact to product quality, and impact to system integrity.

pivotal point

CSA- Same Regulations; Different perspective

A system whose software does not impact Patient Safety, Product Quality is considered Non-GxP, e.g., Systems or Tools used for Document Management, Compliance Management, and Lifecycle Management. The risk associated with such systems is low, and the same level of rigor on Testing, Documentation is not needed.

GxP systems (Systems having a direct impact) such as LIMS, MES, Adverse event reporting have a higher risk of impacting Patient Safety and Product Quality. Hence such systems require adequate Testing and sufficient documentation. In a nutshell, the higher the risk, the higher the need for detailed Testing and Documentation.

The below picture depicts how CSV and CSA differentiate from one another without compromising on the regulation requirements. This is done while keeping in mind the critical aspect  of documentation, which takes a lot of time and effort in a System Validation process for a Life Sciences Company.

pivotal point

Conclusion & Next Steps

To adopt CSA (future of validation?), one needs to conduct a GAP Assessment of the current CSV process within the organization to be able to make the shift from the traditional way of validation.

Many organizations are piloting smaller programs to implement this approach, as it is a cultural shift to make this transition successful However, the most crucial aspect that organizations should not forget is applying critical thinking to make Testing more efficient while maintaining the effectiveness to truly differentiate the traditional way of executing validation using Computer System Validation.

References: ISPE GAMP 5