A Perspective on Computer Validation - Pharmaceutical Technology

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A Perspective on Computer Validation
This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.


Pharmaceutical Technology




In the early years, trying to champion and implement computer validation was quite challenging. The industry faced the unfamiliar installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) concepts. The common reaction to computer validation back then was quite similar to the Kübler–Ross "Five Phases of Grief" cycle (1). Some readers may have similar recollections and probably have heard some of the following responses:
  • Phase 1, Denial: "Our mission is to implement systems, not to write documents and fill out forms," or "Who says we have to do it, show me the regulations."
  • Phase 2, Anger: "We have years of experience in developing and implementing systems, we don't need !@#$*** validation," or "You are joking, you want me to do what?"
  • Phase 3, Bargaining: "Do we have to do all of those things?" or "Can we do this instead...?"
  • Phase 4, Depression: "This feels similar to paying a luxury tax," or "This is stressing me out, I don't have the time and resources to do all this work."
  • Phase 5, Acceptance: "Oh well, fine, if you really want me to do it, I'll do it."

Nowadays, although there are some who are still in the denial stage, the level of grief is more subdued, and the industry is more accepting. For many, computer validation has become a part of daily life, just like accepting and using the mandatory car seatbelt. The road to acceptance was not without its controversies. In the mid 1990s, many varied opinions led to confusion about the scope of computer validation. At one point, a computer's operating system (OS) was thought to be in scope and to require validation, and the OS vendor had to be audited. In another case, a consultant advised that a "change control" must be filed when replacing a printer's toner cartridge (now we know that consumables don't need change control). It was during this period of confusion that "common sense" became the buzz phrase and "it depends" were the first two words that preceded an answer to any computer validation question.

We have transitioned from the "common sense" and "it depends" environment to a risk-based and risk-management environment, especially since the US Food and Drug Administration is on board with risk management (2). We hope that a risk-management approach will level off the inconsistencies inherent to the "it depends" approach. Only time will tell whether it will be successful. By this transition, however, it seems that along the way we have inadvertently proved Darwin's theory of evolution: we have evolved and transitioned from a less-structured environment to a more technically structured and scientifically minded methodology to computer validation.


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