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.