In continuation of our previous article on Computer Software Assurance (CSA), we ask: Is your organization ready to make the change from Computer System Validation (CSV) to CSA?
While CSV placed a major emphasis on documentation, the primary emphasis for Computer Software Assurance is on critical thinking. It reduces the level of documentation that is required by taking a risk-based approach to validation instead of approaching all validation with the same level of risk. However, it can be challenging to transition to CSA due to the changes that must be made to your people, process, and technology.
Making the change to Computer Software Assurance will require training your people on the new process and technology. It may require enlisting the services of an entirely different group of people who have the expertise necessary for this approach. CSA will require shifting your organization’s culture from focusing on compliance to focusing on quality. You will need an effective communication plan and training programs to support this new approach.
Changing from CSV to CSA may involve shifting from a traditional waterfall methodology to an agile methodology. With an agile approach, continuous delivery enables you to test the quality of the system throughout its lifecycle rather than solely at the end of a release cycle, reducing risk. It is key to avoid getting stuck in a hybrid model of using both waterfall and agile, which often does not yield expected results. This requires an agile coach to lead the entire team in the same direction. It will involve cultural changes which require the backing of the strongest driving forces available in the organization.
With the change to CSA, your technological landscape will also be impacted. The technology may shift from traditional waterfall project planning tools such as Microsoft Project to agile planning tools, such as Azure DevOps. While your artifacts may currently be stored as Microsoft Word and PDF documents, going forward, you may consider moving them to a cloud-based digital asset management system to enhance collaboration and enable strict security controls.
In summary, you will need a new technology and a new way to deliver validation artifacts, which your team members will need to be familiar with. To accomplish these goals, you will require training and partnerships with experts who can help you to complete this transition.
To learn more about Computer Software Assurance, please contact a member of the Prana Life Sciences team.
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