Clarkston recently completed an outside-in perspective to identify opportunities for computer system validation (CSV) simplification and alignment to the anticipated computer system assurance (CSA) guidance document from the FDA for a pharmaceutical client. The client engaged Clarkston’s Quality and Compliance team for a CSV to CSA assessment.
The client’s Technical Operations group and, more specifically, Quality Assurance, were interested in identifying opportunities to simplify the current processes to reduce the complexity and timeline for computer system validation projects. This project was important not just for process simplification, but also to support a project to move to a paperless validation solution.
The first phase of the process was an objective assessment of the company’s readiness to shift to CSA. This assessment established the baseline for a deep dive into business and process documentation, process flows, and overall approach to CSV. CSA will introduce a paradigm shift for many companies, as the focus moves from spending most of the time on documentation for audit purposes, to moving to testing high-risk scenarios. Paperwork will be reduced by using unscripted and ad-hoc testing as well as leveraging subject matter experts (SMEs), prior training, and system experience.
The focus on this engagement was on U.S.-centric processes and alignment with the industry standard for the computer system lifecycle. Ensuring the right documents are in place for each stage of the computer system lifecycle is a good indicator of process complexity and risk of duplication across processes. Supplier risk assessment is often performed as part of the supplier selection process; in this example, the supplier of the computer system was referenced as part of the overall computer system risk assessment.
Throughout the project, the team noted opportunities for improvement beyond the process simplification and readiness for CSA. This outsider view into a process that has been in place for many years allowed the client to consider the recommendations to add process maps to documents, simplify content, and combine documents for a more streamlined, simplified approach to CSV, which would support both moving to a paperless validation solution and quick adoption of the highly anticipated CSA guidance document from the FDA.
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Contributions from Linda Plumley