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August 21st and 22nd, 2025
Virtual
As the global pharmaceutical sector accelerates its digital transformation, traditional Computer System Validation practices are being reconsidered in favor of smarter, risk-based methodologies. At the forefront of this evolution is Computer Software Assurance a strategic framework developed by the U.S. FDA that emphasizes critical thinking, focused testing, and operational efficiency without compromising compliance.
In response to this shift, Eminence Business Media has announced the 5th Computer Software Assurance 2025, a virtual gathering on August 21st and 22nd is set to bring together pharma’s top validation minds. The event is positioned as a strategic leadership forum, addressing the real-world complexities of aligning compliance with innovation in a tech-driven regulatory landscape.
The CSA guidance, issued by the FDA in 2022, represents a transformative leap from documentation-heavy validation to a risk-based approach that prioritizes patient safety, product quality, and data integrity, while significantly reducing the validation burden on non-critical systems. It paves the way for regulated life sciences companies to confidently adopt AI, cloud, agile, and DevOps methodologies.
India, home to over 3,000 pharmaceutical companies and producing nearly 60% of the world’s vaccines, is only beginning its CSA journey. While multinational subsidiaries and export-led manufacturers have initiated pilot projects, widespread adoption remains limited. A 2024 Frost & Sullivan report revealed that just 28% of Indian pharma companies had started CSA transitions, and more than 60% faced challenges integrating validation into agile and AI workflows.
Under the theme ‘Rewriting Pharma Validation with CSA, AI & Agile Innovation,’ the conference will offer:
As regulatory expectations evolve and digital adoption accelerates, 5th CSA 2025 arrives at a crucial time, not only to bridge compliance gaps but to emerge as a leader in global digital validation standards.
Because in today’s pharma world, compliance isn’t a roadblock. It’s a catalyst for innovation.
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