The CSA Draft Guidance recommends a Risk-Based Computer Software Assurance Framework for computers and automated data processing systems used by manufacturers for production and/or quality system purposes.
In this webinar, we will be discussing the FDA’s recommendations for a viable risk-based computer software assurance framework:
• Identifying the intended use of the software.
• Determining appropriate risk-based approaches
• Determining appropriate assurance activities
• Establishing appropriate records
Speakers
Khaled Moussally
Executive VP Quality – Clients & Regulatory Relations at Compliance Group Inc
Ron Schardong
Head (Senior Director), Johnson & Johnson
Ray Murphy
Software Quality Engineering Fellow, Boston Scientific