Key Takeaway:

Organizations that implement a risk-based approach to computer system validation decrease, in the long run, time and cost overruns associated with validation.
Computer system validation is a must for organizations involved in a number of businesses and activities. Regulatory authorities such as the FDA, apart from the European Medicines Agency (EMEA), Medicines and Healthcare Products Regulatory Agency and the Ministry of Health, Labor and Welfare (MHLW) of Japan exhort organizations under their purview to implement a risk based computer system validation.
Yet, there is general widespread reluctance about its implementation, because many organizations are concerned at the apparent high costs associated with risk based CSV. Many are fine with the general, mechanical elements of CSV, such as implementing methodologies, processes and documentations, but are somehow loathe to the idea of implementing a computer system validation that is risk based. Most of the reservations organizations have are centered on:
  • Lack of clarity about standards to be implemented or their overlap
  • Lack of a robustly structured quality system
  • Existence of myriad interpretations and opinions
  • Low or total lack of exposure to CSV
  • Perception of low returns and immeasurable improvement in quality on relatively high investment
Despite all these skepticisms, a risk based approach to computer systems validation is considered a vastly improved methodology over the traditional system of validating everything for everything. With the coming into existence of21 CFR Part 11; there has been a shift in focus from validating everything to validating the core, critical aspects of CSV.

Why a risk based approach to CSV?

The need for importance of a risk based approach to computer system validation has to be understood from the following standpoints:

Principles of risk based computer system validation

Risk based CSV is primarily run on two major principles:
Risk based CSV involves inputs of some additional costs in the short run, but the organization that implements it gets its risk identification, assessment and mitigation right and saves in the long run.
Read More: https://www.linkedin.com/pulse/risk-based-computer-system-validation-remedy-methods-ronald-gardner?trk=mp-reader-card