Computer System Assurance in Support of Manufacturing 4.0
By: Daniel R. Matlis, President
Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in the Life-Sciences. Medical Device Executives believe this new approach will result in a 30% to 50% reduction in time and cost, and will increase and accelerate improvements and innovation.
This eBook includes success stories and first-hand examples by:
Francisco (Cisco) Vicenty, Program Manager – CfQ, US FDA
Jason Spiegler, Sr. Director, Industry Portfolio Development, Siemens PLM
Damien McPhillips, Sr. Quality Manager – Global Software and Digital Health, Boston Scientific
Ray Murphy, Principal Software Quality Engineer, Boston Scientific
April Francis, Director Global IT Quality and Compliance, Medtronic
Frank Melendandri, Sr., Manager, Quality Assurance, Zoll Lifevest
This paradigm shift has had an enormous impact on the industry. Backed by the FDA, a new era of computer system validation is here. According to Cisco Vicenty, CfQ Program Manager at FDA: “All the recommendations that the Non-Product CSV Guidance is highlighting, is within scope of the FDA’s QSRs and is compliant.”
This eBook covers:
- Background and Barriers to CSV
- A Paradigm Shift in Non-Product CSV
- FDA’s Case for Quality and Perspective on CSV
- CSV Risk-Based Recommendation Approach
- Vendor Qualification
- Analytics and Reporting
- Risk Matrix for Systems that Provide a GxP Function
- CSV Paradigm Shift
- Automated CSV Risk Management
- A New Era for CSV
Read more in this Axendia eBook presented by Siemens.
Hear directly from FDA on this topic in our “Straight from the Source” Webinar, now available on demand.