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
