Risk-Based Computer Software Assurance & Validation Guide 2025

In today's rapidly evolving life sciences and pharmaceutical industries, staying compliant with FDA, MHRA, and EU Annex 11 regulations is no longer just a checkbox—it's a critical foundation for success. With the increasing reliance on digital systems, Computer Software Assurance (CSA), data integrity, and cloud-based solutions have become essential for meeting regulatory expectations while maintaining operational efficiency.

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