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Understanding the FDA's New Approach to Computer System Validation

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While computer systems and technology have evolved at an exponential rate over the last 20+ years, the approach to validating them has not kept pace. Computer System Validation (CSV) can be a significant obstacle to the implementation and management of software solutions, often due to a lack of clarity from FDA on CSV expectations.

As a result, the industry’s efforts have focused on a compliance-centric approach resulting in low rates of investment in software technology to deliver automation and digital capabilities across the Life-Sciences industry. This has hampered digital transformation in the industry, a trend that the FDA has recognized and is working swiftly to help reverse.

As Life Science companies strive to achieve digital transformation, a new and streamlined approach to CSV is required. Join this on-demand webinar where we discuss: 

  • The FDA’s upcoming Guidance on Computer Software Assurance for Manufacturing, Operations, and Quality System Software
  • How to apply critical thinking and risk-based principles when developing assurance approaches 
  • The level of effort required to assure computer system operation in this new paradigm
  • Specific approaches companies can use to support Manufacturing, Operations, and Quality 
  • Real-world examples from Life-Science companies using this approach
  • How to use Assurance approaches to accelerate digital transformation

Speakers

Speaker 1

Gon Brown

Gettyimages, Founder
Speaker 2

Gon Brown

Gettyimages, Founder
Speaker 3

Gon Brown

Gettyimages, Founder
Speaker 4

Gon Brown

Gettyimages, Founder

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