John Robinson
May 29 - 30, 2014 - Sydney CA USGlobalCompliancePanel
support@globalcompliancepanel.com
Phone:8004259407
Fax:302-288-6884
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry . It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV continue to be on the rise. It is estimated that 1 in 5 of Medical Device Recalls are due to incorrect CSV. Currently, there are many outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) that include citations for CSV. This is expected to further escalate as technology advances and companies need to consider Cloud Technologies, as well as patient privacy issues such as HIPAA Costs of not understanding CSV are enormous: One 2013 incorrect implementation of CSV resulted in fines of up to $3Billion. Software Projects requiring CSV often overrun by several months. Corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. More importantly, CSV is a foundation to other discovery, development & commercialization of products and CSV failure includes failure of those efforts.