Literature

Computer Software Assurance

Computer Software Assurance

Value Beyond Compliance

Rick Ruiz, Principal, Tunnell Consulting

The Life Sciences marketplace is taking on many of the characteristics of the retail marketplace–speed to market, global competition, generic products, and a variety of challenging pricing models. Getting to market is incredibly important and significantly challenging to Life Sciences companies. One of their most significant challenges is successfully providing that their systems are safe and can produce effective and safe products.

In order to overcome that hurdle companies have been required to perform a Computer System Validation (CSV) of their business systems for safety reasons. Unfortunately, for the amount of time and resources needed to perform the validation, it has returned little value to the business. It is for this reason, and other associated reasons, companies are moving away from the traditional CSV to the more innovative Computer Software Assurance (CSA) approach.

Traditionally, CSV has been a very tedious and long process that companies had to endure. The CSV approach is viewed as an activity that is lengthy in completion, is a challenge to speed to market, and typically results in very little value to the business. Due to challenges related to the traditional CSV and the advent of advanced technology, there has been a significant movement towards a radically different approach. The FDA has appropriately reconsidered the CSV approach and is trying to assist companies in keeping the focus on patient and product safety while supporting speed to market. The change has resulted in the innovative approach of Computer Software Assurance (CSA).

CSA can reduce the validation time by 20% to 40% and, more importantly, it can significantly increase quality. The approach is now more of a risk-based approach that leverages “critical thinking” rather than just brute force through the validation. This risk-based approach requires practitioners to intelligently evaluate the system functionality, become more educated on the business processes and drive more quality into the system software. Moving to a CSA approach results in a higher quality system.

New technology such as Cloud environments and Enterprise Resource Planning (ERP) have had a significant impact on the validation process. The Cloud environment has radically changed the approach to hardware infrastructure and installation. Cloud technology leverages a standardized vendor platform whose configuration and management is the responsibility of the vendor.

The ERP has had a significant impact on the validation process. One of the goals of an ERP is to incorporate the best practices of a business. For instance, Oracle Cloud Fusion can perform many Critical Business Processes (CBP) with no, or very little, modification to the software. Leveraging an ERP drives down the risk factor associated with the successful execution of processes on a consistent and reliable fashion.

ERPs and Cloud technology also incorporate other components such as built-in cyber- and system-base security, intelligent data transformation and data integrity, and intelligent interfaces that support accelerated validation due to the reliability of the components.

The traditional CSV approach can now be transitioned to the CSA approach for a more reliable and higher quality system.

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