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Those in computer systems validation (CSV) need to avoid 483’s/Warning Letters One of the prime requirements for those in CSV, also known as Software Validation, apart from coming out with quality output, is avoiding 483’s/Warning Letters from the FDA. Computer Systems Validation (CSV) being a prime element of the Life Sciences Industry; is bound by all the predicate rules, as well as 21 CFR 11 and Annex 11. Of these, Annex 11 impacts all areas of ICH Q9 and ICH Q10. This is the basis to avoiding 483’s/Warning Letters from the FDA. Knowledge of how to implement CSV is very important This fact appears rather simplistic in theory, but in practice, it is quite difficult to detect these requirements for CSV, and even harder to determine what needs to be done to meet domestic and/or international regulations or business continuity requirements, if one does not know how to implement CSV. As if this was not complicated in itself, the FDA has increased the number of 21 CFR 11 inspections that include CSV. A series of complications Since the increase in 21 CFR 11 inspections that include CSV; it is only logical that the number of 483s/Warning Letters due to CSV is on the rise. Incorrect CSV is at the root of a very high one-fifth of all Medical Device Recalls. Among the several outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.), a high number includes citations for CSV. However, this is the not the end, but the beginning of this grim scenario: this situation is expected to further escalate as technology advances and companies need to consider Cloud Technologies and, as well as in view of patient privacy issues such as HIPAA Be prepared for gargantuan costs What happens when an organization fails to get a proper understanding of CSV? Mention of a small fact can give an idea about the humungous costs involved: In 2013, one incorrect implementation of CSV in 2013 resulted in fines of up to an astounding $3 billion. Noncompliant CSV can bring about other roadblocks: Software Projects requiring CSV often overrun by several months, and corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. CSV is the pathway to other discovery, development and commercialization of products. So, CSV failure can lead to failure in those efforts, as well. What does ensuring CSV involve? Thus, ensuring CSV and preventing all the troubles associated with lack of it medical device companies is a cornerstone for medical device companies. An understanding of the following can go a long way in stabilizing this cornerstone: o Overview of Life Sciences Lifecycle (ICH Q10) and how CSV fits into it o Detecting CSV in predicate rules/guidances o CSV in 21 CFR 11/Annex 11 o The FDA’s 21 CFR 11 Add-On Inspections o CSV components and deliverables o CSV & ICH Q9 (Risk Assessment) o Validation Plan o Requirements Specifications o Functional Specifications o Design Specifications o Software Configuration and Build o Traceability Matrix o Verification and Testing o Validation Report o Validation Registry o CSV for Excel and other spreadsheets o Project Management for CSV o How to audit CSV projects Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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