The extreme importance of Quality Assurance for Computer Systems Validation (CSV)

Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11.

Knowledge gap

Many companies have a difficulty in determining what needs to be done, to meet domestic and/or international regulations or business continuity requirements, as a result of which Quality Assurance for Computer Systems Validation becomes incomplete. On top of these, as if these issues were not enough, the FDA has escalated 21 CFR 11 inspections that include CSV, making the already difficult task of requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11 all the more complex. Something like a fifth of all incorrect Medical Device Recalls is attributed to unfulfilled Computer Systems Validation, meaning that Quality Assurance is a big casualty.

Bleak future

What does a prognosis of this scenario look like? If anything, the number of recalls and Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) due to the product’s inability to meet Quality Assurance for Computer Systems Validation is set to go up. The reason behind this outlook is that technology is advancing, which brings with it many attendant pitfalls. And, as companies consider Cloud Technologies; there are sure to be patient privacy issues such as HIPAA involved in all this.

Roll up your sleeves; get your CSV right!

The costs associated with lack of implementation of Quality Assurance for Computer Systems Validation is quite shocking. In 2013, a single incorrect implementation of Quality Assurance for Computer Systems Validation resulted in fines of up to $three billion. It is but natural that software projects that need CSV get overrun by long periods of time. Corrections required to be implemented into a system that has been issued a 483 due to Quality Assurance for Computer Systems Validation can cost a quarter of a million dollars. Imagine the sheer amount of money needed when multiple issues are found.

Yet another critical reason, for which Quality Assurance for Computer Systems Validation has to be met, come what may, is that CSV is a foundation to other discovery, development & commercialization of products. So, not meeting Quality Assurance for Computer Systems Validation can result in a spiral: all the concomitant and ensuing efforts go waste.

All of this means that the need to meet Quality Assurance for Computer Systems Validation could not be more urgent or important.

GlobalCompliancePanel

 

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