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 Axendia & Sparta Systems for this live webinar where they will 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
Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With nearly three decades of experience, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster while minimizing product risks and ensuring compliance. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality.

The combination of Sparta Systems and Honeywell brings together Sparta’s quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.